Low Incidence Of Infection Research Articles

Venetoclax Plus Azacitidine, Low Dose Cytarabine, Aclarubicin and G-CSF (VA-CAG Regimen) for Newly Diagnosed Young Patients with Acute Myeloid Leukemia: A Prospective, Multicenter, Single-Arm Phase 2 Clinical Trial

Background: Venetoclax, in combination with hypomethylating agents or low-dose cytarabine, is approved for newly diagnosed acute myeloid leukemia (AML) patients who are over 75 years of age or not eligible for intensive chemotherapy, while the efficacy of venetoclax-based regimens in young fit AML patients still needs to be further explored. Although the combination of anthracycline and cytarabine has achieved a remission rate of about 70% in these patients, the low complete response rate in adverse-risk patients, strong adverse reactions, and long duration of myelosuppression limited the clinical benefit. We presumed that venetoclax plus azacitidine in combination with low-intensity regimens CAG (G-CSF priming, low dose cytarabine, and aclarubicin) could have a better composite complete remission with an acceptable safety profile. Methods: Patients who were newly diagnosed with AML aged from 18 to 65 years without active infection, bleeding and severe cardiopulmonary insufficiency were enrolled. Participants received induction as azacitidine 75 mg/m 2 subcutaneously once daily on days 1-7, cytarabine 10mg/m 2 subcutaneously q12h on days 1-7, aclacinomycin 12 mg/m 2 on days 1,3,5,7, granulocyte colony-stimulating factor 5µg/kg on days 1-7, and venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21). Venetoclax dose was adjusted based on concomitant CYP3A inhibitors. The efficacy were evaluated by bone marrow morphology and flow cytometry on day 28 cycle 1. The primary endpoints were safety and the composite complete remission rate. This study was approved for ethical review and registered with ClinicalTrials.gov (NCT05662956). Results: Twenty-six patients from eight sites were enrolled between January 1, 2023, and June 20, 2023. The median age was 52 years (range, 18-63years). Thirteen patients (50.0%) had adverse risk, 7 patients (26.9%) had intermediate risk, and 6 patients (23.1%) had favorable risk. All 26 patients (100%) achieved complete remission after cycle 1, and 21 patients (80.8%) was MRD negative by flow cytometry. Two patients (7.7%) were treated with venetoclax for 14 days due to ineffective platelet transfusion and severe infection during treatment. Twenty-two patients (84%) used azole drugs to prevent fungal infection. The median myelosuppression time was 13 days (range, 5-22days), and the median red blood cell and platelet transfusions were 5.5u (range, 0-11.5u) and 30u (range, 0-170u), respectively. Eleven patients (42.3%) experienced infection (including pulmonary fungal infection, oral cold herpes, novel coronavirus infection, etc.), and two of them (7.7%) had a breakthrough invasive fungal infection, but with good management. The most common grade 3/4 adverse events included bone marrow suppression (92.3%), liver injury (19.2%), gastrointestinal reaction (11.5%) and coagulation dysfunction (3.8%).No treatment-related death occurred. Conclusion: VA-CAG regimen achieved high rates of complete remission and MRD negative in young adult fit patients with newly diagnosed AML. This combined regimen has an acceptable safety profile, with low incidence of infection and transfusion dependence.

Safety and durable patency of tunneled hemodialysis catheter inserted without fluoroscopy.

A tunneled hemodialysis (HD) catheter is preferred due to its lower incidence of infection and malfunction than non-tunneled ones. For safer insertion, fluoroscopic guidance is desirable. However, if the patient is unstable, transfer to the fluoroscopy may be impossible or inappropriate. From June 2019 to September 2022, 81 tunneled HD catheter insertion cases performed under ultrasound guidance without fluoroscopy and 474 cases with fluoroscopy in our institutional HD catheter cohort were retrospectively compared. Immediate complications, later catheter-associated problems, including infections and catheter dysfunction, were comparable between the two groups (p = 0.20 and p = 0.37, respectively). The patency of tunneled catheters inserted without fluoroscopy was comparable to the patency of tunneled catheters inserted with fluoroscopic guidance (p = 0.90). Tunneled HD catheter insertion without fluoroscopy can be performed safely and has durable patency compared to the insertion with fluoroscopy. Therefore, this method can be considered for the selected unstable patients (e.g., ventilator care) in the intensive care unit.

Invasive aspergillosis in liver transplant recipients, an infectious complication with low incidence but significant mortality.

Infections, including invasive fungal infections (IFIs), are among the leading causes of mortality in liver transplant recipients during the first year post-transplantation. To investigate the epidemiology, clinical manifestations, risk factors, treatment outcomes, and mortality rate of post-liver transplantation invasive aspergillosis (IA). In this case-control study, 22 patients with IA were identified by reviewing the archived and electronic medical records of 850 patients who received liver transplants at the Imam Khomeini Hospital complex in Tehran, Iran, between 2014 and 2019. The control group comprised 38 patients without IA infection matched for age and sex. The information obtained included the baseline characteristics of liver transplant patients, operative reports, post-transplantation characteristics of both groups and information about the fungal infection of the patient group. The prevalence rate of IA among liver transplant recipients at Imam Khomeini Hospital was 2.7%. The risk factors of IA among studied patients included high serum creatinine levels before and post-transplant, renal replacement therapy, antithymocyte globulin induction therapy, post-transplant bile leakage, post-transplant hepatic artery thrombosis, repeated surgery within 30 d after the transplant, bacterial pneumonia before the aspergillosis diagnosis, receiving systemic antibiotics before the aspergillus infection, cytomegalovirus infection, and duration of post-transplant hospitalization in the intensive care unit. The most prevalent form of infection was invasive pulmonary aspergillosis, and the most common chest computed tomography scan findings were nodules, pleural effusion, and the halo sign. In the case group, prophylactic antifungal therapy was administered more frequently than in the control group. The antifungal therapy response rate at 12 wk was 63.7%. The 3- and 12- mo mortality rates of the patients with IA were 36.4% and 45.4%, respectively (compared with the mortality rate of the control group in 12 mo, which was zero). In this study, the prevalence of IA among liver transplant recipients was relatively low. However, it was one of the leading causes of mortality following liver transplantation. Targeted antifungal therapy may be a factor in the low incidence of infections at our facility. Identifying the risk factors of IFIs, maintaining an elevated level of clinical suspicion, and initiating early antifungal treatment may significantly improve the prognosis and reduce the mortality rate of liver transplant recipients.

Minimally Invasive Percutaneous Plate Osteosynthesis versus Interlocking Intramedullary Nail Fixation in Treating Extra-Articular Distal Tibial Fractures in Adults. A Systematic Review

Background IM nailing and MIPPO fixation remain viable options for management of distal tibia fractures. IM nailing provides superior operation time, union time, and time to full weight-bearing as well as a lower incidence of superficial and deep infection, but may provide inferior alignment and is associated with residual knee pain. MIPPO fixation provides superior alignment and avoids knee pain, but it has a higher rate of soft-tissue complications and hardware irritation. This review revealed that MIPPO has a higher risk of both superficial and deep infection among patients treated with MIPPO compared to IMN. In the MIPPO technique, 15% developed a superficial infection, compared to 7% after IMN, and 14% developed a deep infection, compared to 6.3% after IMN. Aim of the Work to provide a complete overview of the optimal surgical treatment of distal tibia fractures by evaluating and comparing the clinical and functional outcomes of minimally invasive percutaneous plate osteosynthesis (MIPPO) vs Interlocking intramedullary nail (IMN) for treating extra-articular distal tibial fractures. Outcomes of interest include operation time, time to union, non-union, mal-union, infection, secondary operations, and functional outcomes (quality of life scores and ankle scores). Patients and Methods In terms of union complication, IMN has a higher incidence of malunion which occurred in 14.7% of the patients after IMN compared to 8.8% after MIPPO fixation. The incidence of non-union was similar in both treatment methods, it occurred in 3.5% of patients. In addition to union rate, the union time was significantly shorter after IMN fixation compared to the MIPPO technique especially in AO 43A fracture type and the closed fractures. The mean time for union was 18 weeks in IMN compared to 20 weeks in MIPPO. Results Nine studies including 813 patients reported on operation time with an overall weighted mean operation time of 74.1 minutes (range 56.4 – 124 minutes) in IMN and 85.4 minutes (range 51.4 – 124 minutes) in MIPPO. The operation time in the IMN was significantly shorter compared to MIPPO (WMD -11.24 minutes, 95% CI -15.44 to -7.05, P < 0.05) with significant moderate heterogeneity (I2 = 68%). Conclusion Based on this study, both MIPPO and IMN have similar therapeutic efficacy regarding the functional outcome and can be used safely in distal tibial extra-articular fractures. Although IMN is advantageous over MIPPO with a lower incidence of infection and implant irritation symptoms, shorter operation time, earlier weight-bearing, and earlier union, it leads to a higher rate of mal-union and anterior knee pain. Overall, choosing an implant based on the findings of this meta-analysis is difficult and should be done on a caseby-case basis. Patients who have a high risk for infection (due to high age, comorbidities, smoking, or severe soft tissue injury) should preferably be treated with a nail. MIPPO fixation may be more beneficial to young, active, and healthy patients who are less prone to infection because it reduces the risk of knee pain and mal-union.

Antibiotic Prophylaxis in the Management of Distal Fingertip Amputation and Crush Injury

We sought to investigate the role of prophylactic antibiotics for distal fingertip crush injury or transphalangeal amputation treated outside of an operating room and better understand the factors that contribute to antibiotic-prescribing decisions. We hypothesized that prophylactic antibiotics do not meaningfully reduce the incidence of infection and that antibiotics are prescribed in a predictable way. This is a retrospective review of all patients treated in a MedStar-affiliated emergency department or urgent care for nonsurgical distal fingertip trauma in 2019. Patient demographics, comorbidities, injury characteristics, interventions, and follow-up details were recorded. Exclusion criteria included signs of infection at the time of presentation, minor injuries not requiring intervention, bite wounds, one-time intravenous antibiotic administration without oral course, and surgical intervention. Outcomes included infection and interventions at follow-up. Chi-square analysis was performed, comparing antibiotic and no-antibiotic groups. A stepwise binomial regression was used to evaluate for variables predictive of antibiotic prescription. We identified eight infections in 323 patients included in the study (2.5% incidence of infection). There was no statistically significant difference in the incidence of infection between patients treated with antibiotics (2.7%) and those who did not receive antibiotics (2.2%). However, due to the low incidence of infections, we were likely underpowered for this analysis. We also created a model to predict antibiotic prescribing, which achieved an area under the receiver operating characteristic curve of 0.86 (P < .0001) based on age, bleeding disorders, depressive disorders, open wound status, amputation, fractures, and encounter type. The low incidence of infection (2.5%) and lack of a meaningful difference between the groups call into question prophylactic antibiotic prescribing after these distal fingertip injuries. Our model does predict provider prescribing habits, identifying areas for potential practice pattern change. Therapeutic III.

Evaluation of Humeral Shaft Fracture Outcomes by Treatment Method: A Systematic Review and Meta-analysis Based on Comparison Studies.

The purpose of this systematic review and meta-analysis was to evaluate various outcomes of humeral shaft fractures treated with different treatment methods, which included functional bracing, open reduction and internal fixation, intramedullary nailing, and locked compression plate. A systematic review was performed using research databases including PubMed, EMBASE, and Google Scholar. Keywords relating to treatment of humeral shaft fractures were used, and comparison studies that reported patient characteristics and outcomes, including nonunion, malunion, function scores, and complications, were included. One hundred fourteen records were screened, with 18 studies ultimately included in the meta-analysis. Treatment groups were consolidated into brace or surgery and then further categorized into subgroups based on surgical technique used. Postoperative events, complications, and functional scores were compared among the treatment groups. Statistical analysis for this study was conducted using Review Manager 5.3, with a standard p-value of ≤0.05 for statistical significance. Eighteen studies were included in this review with a total of 706 patients. Z-tests showed that risks of revision, nonunion, and malunion were higher in the brace treatment group compared with the surgical treatment group (p < 0.0001, <0.0001, 0.004, respectively). Risk of infection was expectedly higher in the surgical group compared with the brace group (p = 0.04). Radial nerve injury rates were also higher in the unspecified surgical group compared with the brace group (p = 0.01). In the surgical group, the mean Constant shoulder score was also significantly higher than that in the brace group (p = 0.004). When comparing the nail and plate groups, Z-tests revealed higher risks of delayed unions and other complications in the nail group (p = 0.04 and 0.001, respectively) but higher risk of infection in the plate group (p = 0.05). The conservative treatment of humeral shaft fractures with functional braces may be associated with a lower incidence of infection and nerve injury when compared with operative treatment methods. However, nonoperative treatment may also come with higher risks of revision, nonunion, and malunion than the many available surgical modalities. Operative management with either intramedullary nail or plate has shown to be a reliable method of management with reasonable outcomes for humeral shaft fractures. While the nail group had higher risk of delayed unions and other complications, the plate group had higher risk of infections. Both nail and plate surgical treatments have shown to result in high union rates and should be considered by the surgeon on a case-by-case basis when treating humeral shaft fractures. Level I. See Instructions for Authors for a complete description of levels of evidence.

The Association of the Levels of High-Density Lipoprotein and Apolipoprotein A1 with SARS-CoV-2 Infection and COVID-19 Severity: An Analysis of the N3C Database.

This study analyzed data from the National COVID Cohort Collaborative (N3C) database to investigate whether high-density lipoprotein (HDL) and its major protein component, apolipoprotein A1 (apoA1), are associated with severe COVID-19 sequelae, specifically acute kidney injury (AKI) and severe COVID-19 disease as defined by the infection resulting in hospitalization, extracorporeal membrane oxygenation (ECMO), invasive ventilation, or death. Our study included a total of 1,415,302 subjects with HDL values and 3589 subjects with apoA1 values. Higher levels of both HDL and apoA1 were associated with a lower incidence of infection as well as a lower incidence of severe disease. Higher HDL levels were also associated with a lower incidence of developing AKI. Most comorbidities were negatively correlated with SARS-CoV-2 infection, presumably due to the behavioral changes that occurred as a result of the precautions taken by individuals with underlying comorbidities. The presence of comorbidities, however, was associated with developing severe COVID-19 disease and AKI. African American and Hispanic populations experienced worse outcomes, including a higher incidence of infection and the development of severe disease, as well as AKI. Smoking and being male were associated with a lower incidence of infection, while they were risk factors for the development of severe disease and AKI. The results on cholesterol and diabetes drugs warrant further research, given that the database included multiple drugs in each category impeding for analysis of specific medications. Despite the current limitations in the N3C data, this study is the first to investigate the roles of HDL and apoA1 on the outcomes of COVID-19 using the US population data.

Prognosis and incidence of infections in chronic kidney disease patients with membranous nephropathy enrolled in a large Japanese clinical claims database

BackgroundThe treatment of membranous nephropathy involves a combination of conservative approaches, steroids, and immunosuppressive agents. Infection is an adverse effect of these treatments and its incidence is a critical issue for patients with membranous nephropathy, as many of them are older adults. However, the incidence of infections remains unclear; hence, this study investigated this issue using data from a large Japanese clinical claims database.MethodsFrom a database of patients with chronic kidney disease (n = 924,238), those diagnosed with membranous nephropathy from April 2008 to August 2021 with a history of one or more prescriptions and undergoing medical care were included. Patients who had undergone kidney replacement therapy were excluded. Patients were divided into three groups based on their prescriptions after diagnosis: prednisolone(PSL), who received steroids; PSL + IS, who were prescribed steroids and immunosuppressive agents; and C, who were treated without steroid or immunosuppressive agent use. The primary outcome was death or the initiation of kidney replacement therapy. The secondary outcome was death or hospitalization due to infection. Infectious diseases such as sepsis, pneumonia, urinary tract infections, cellulitis, cytomegalovirus infection, colitis, or hepatitis were defined as infections. Hazard ratios were expressed using group C as a reference.ResultsOf 1,642 patients, the incidence of the primary outcome occurred in 62/460 individuals in the PSL group, 81/635 individuals in the PSL + IS group, and 47/547 individuals in the C group. The Kaplan–Meier survival curve showed no significant differences (P = 0.088). The incidence of secondary outcomes occurred in 80/460 individuals, 102/635 individuals, and 37/547 individuals in the PSL, PSL + IS, and C groups, respectively. The incidence of secondary outcomes was significantly higher in the PSL group (hazard ratio [HR] 2.43 [95% confidence interval [CI] 1.64–3.62, P < 0.01]) and PSL + IS group (HR 2.23 [95% CI 1.51–3.30, P < 0.01]).ConclusionsThe outcome of membranous nephropathy was not completely satisfactory. Patients who use steroids and immunosuppressive agents have a high incidence of infection and may require close monitoring during the course of treatment.High-efficacy treatment with a low incidence of infections is desirable. The significance of this study lies in the fact that the impressions of membranous nephropathy, which have been recognized as tacit knowledge, were quantified using a clinical database.

Pre-Endoscopy real-time PCR testing for SARS-CoV2 does not reduce health care workers infection and is associated with a higher reduction of endoscopic activity in an outpatient setting.

The role of pre-procedure SARS-CoV2 testing in digestive endoscopy is still debated. AGA guidelines recommend against pre-procedure testing considering low prevalence of SARS- CoV2 infection in the general population and low incidence of infection among endoscopy units Health Care Workers (HCWs). However, no studies have compared pre-procedure testing associated to symptom screening vs. symptom screening alone in reducing the risk of infection for HCWs. Main aim of the present study is to compare the risk of infection for HCWs in different Endoscopy Units adopting different pre-endoscopy screening and operating in two nearby hospital of the same region in Northern Italy in pre-vaccination period. For outpatients in the Endoscopy Unit of Trento (Unit 1) only pre-procedure symptom screening was performed, while in the Endoscopy Unit of Bolzano (Unit 2) pre-procedure symptom screening and negative pre-procedure real-time PCR were requested. Secondary aims were to assess the impact of pre-procedure real-time PCR testing on endoscopic activity and diagnostic delay. Retrospective data collection on a prospectively maintained database was performed, including outpatient endoscopy procedures performed between June 1st 2020 and February 28th 2021 in Unit 1 and Unit 2. No differences in terms of infection rate in HCWs have been identified in Unit 1 and Unit 2 (9.0 vs. 19.3% P=0.2) over a nine-month period. Moreover, in the unit performing pre- procedure real-time PCR before endoscopy a significantly higher reduction in endoscopic activity has been recorded (61.9% vs. 53.4%; P<0.01). In patients with positive real-time PCR, endoscopy was performed with a mean delay of 61.7 days (range 9-294) and 22.5% of them were lost at follow-up and did not undergo any endoscopic procedure in the following 12 months. This study supports the AGA recommendation suggesting that pre-endoscopy real-time PCR is an expensive and time-consuming procedure without proven benefits in an outpatient setting.

Impact of the COVID-19 pandemic and associated lockdown measures on the management, health, and behavior of the cystic fibrosis population in France during 2020 (MUCONFIN).

Most of the studies on cystic fibrosis (CF) focused on SARS-CoV-2 prevalence and suggested a low incidence of infection in this population. We aimed to assess the impact of the pandemic and related lockdown measures implemented in May 2020 in response to the first wave of SARS-CoV-2 infection on healthcare access, health, and behavior in CF patients. A national questionnaire opened online from May 15th, 2020 to June 11th, 2020 was completed by 751 CF-patients, aged 14 years and over. It comprised questions about access to healthcare, anxiety and depression, smoking, alcohol, drug and psychotropic drug consumption, adherence to CF treatment, and constraints. A semi-structured comprehensive interview was performed no later than 1 month after the end of the lockdown in 16 CF-patients. The mean age of the population was 28.0 [interquartile range (IQR) 20.0-37.0] years old. More than 75% of in-person consultations scheduled during the lockdown were canceled. Alternatively, 27% were postponed, and telehealth consultations were proposed and accepted in almost 40% of cases. More than 75% of the scheduled physiotherapy sessions were canceled and replaced mainly by self-drainage. Annual follow-up clinic visits were consistently postponed whereas required hospitalizations at CF centers for exacerbation were maintained in most cases. While 43.2% CF-patients had signs of anxiety, 51.0% presented symptoms of depression, both associated with increased use of psychotic medications and inversely correlated to COVID-19 prevalence. Among the lower and lower middle classes, very little medical information was obtained or requested by the patient, participation to sports or other activities was low, while excessive home confinement and isolation were more frequent. In contrast, in the upper middle and upper classes, individuals solicitated help to their CF centre, had more physical activities, and maintained contact with friends or families. The first lockdown in France had only minimal impact on the management care of CF-patients but was associated with increased symptoms of anxiety and depression, together with behavioral changes that varied with social class. NCT04463628.

Systematic review of groin wound surgical site infection incidence after arterial intervention.

The objectives were to determine the surgical site infection incidence (including superficial/deep) fter arterial intervention through non-infected groin incisions and identify variables associated with incidence. MEDLINE, EMBASE and CENTRAL databases were searched for randomised controlled trials and observational studies of adults undergoing arterial intervention through a groin incision and reported surgical site infection. Infection incidence was examined in subgroups, variables were subjected to meta-regression. One hundred seventeen studies reporting 65 138 groin incisions in 42 347 patients were included. Overall surgical site infection incidence per incision was 8.1% (1730/21 431): 6.3% (804/12 786) were superficial and 1.9% (241/12 863) were deep. Superficial infection incidence was higher in randomised controlled trials (15.8% [278/1762]) compared with observational studies (4.8% [526/11 024]); deep infection incidence was similar (1.7% (30/1762) and 1.9% (211/11 101) respectively). Aneurysmal pathology (β=-10.229, P < .001) and retrospective observational design (β=-1.118, P=.002) were associated with lower infection incidence. Surgical site infection being a primary outcome was associated with a higher incidence of surgical site infections (β=3.429, P=.017). The three-fold higher incidence of superficial surgical site infection reported in randomised controlled trials may be because of a more robust clinical review of patients. These results should be considered when benchmarking practice and could inform future trial design.

Arthroscopic Ankle Arthrodesis with Circular External Fixator: Case Report

Category: Ankle Arthritis; Arthroscopy; Trauma Introduction/Purpose: One of the options for the surgical treatment of tibial pilon fracture is the circular external fixator. Similar results are found in the literature, with good outcomes in relation to a low incidence of infection, osteomyelitis and soft tissue injuries compared to open reduction and internal fixation. Even so, evolution to a probable arthrodesis occurs in 3-27% of cases, showing that the prognosis for this type of fracture is dismal. Options for performing joint fusion include open arthrotomy with joint decortication and internal fixation (plates and/or screws), in addition to arthroscopic joint preparation, a method that has been gaining popularity since 1983, in its first description. Fusion through circular external fixation is an excellent option that has shown good results in the literature. Methods: Patient with left tibial pilon fracture. Uniplanar external fixation was performed in the emergency room, with subsequent conversion to transarticular circular external fixation. After 4 months of review, the patient has evidence of tibiotarsal arthrosis. It was decided to perform arthrodesis using the arthroscopic technique, performing joint compression with circular external fixation, already installed in the patient. Spinal anesthesia was performed on the patient and the Smarch tourniquet was used. First, access to the anteromedial portal, trocar and optic passage was obtained, and the intermediate dorsal cutaneous branch of the superficial peroneal nerve was identified laterally, and the anterolateral portal was constructed. Through these portals, a 4.5mm Shaver blade was used to perform curettage and joint debridement, in addition to curettes and osteotomes. In addition to arthroscopic control, fluoroscopic observation was also performed for adequate joint preparation.Finally, joint compression was performed with the device already installed. Results: The patient presented complete consolidation of the tibio-tarsal arthrodesis. At the moment (2 years and 10 months postoperatively) the patient does not use crutches/gait accessories, does not limit his daily activities due to foot problems, does not have difficulty going down and up stairs, has good ankle alignment, plantigrade foot, has no joint pain and can walk long distances. Conclusion: This work showed a technique rarely reported or cited in the orthopedic literature, not presenting any article as an original description. Supported by the description of the procedure by the robust final functional results of the patient in question, this report establishes the basis for the widespread method and new works to emerge to enrich the debate and study around arthroscopic ankle arthrodesis using the Ilizarov method.

The efficacy and safety of low-dose chemotherapy combined with tyrosine kinase inhibitors in the treatment of Philadelphia-chromosomal-positive acute lymphoblastic leukemia

目的探讨低剂量化疗联合酪氨酸激酶抑制剂（TKI）作为Ph染色体阳性急性淋巴细胞白血病（Ph+ ALL）诱导治疗方案的有效性与安全性。方法回顾性分析2008年1月1日至2021年7月31日北京大学人民医院收治的217例初诊Ph+ ALL患者的临床资料，通过logistics回归和Cox回归分析，比较低剂量化疗与常规剂量化疗的疗效及不良反应。结果研究纳入217例患者，中位年龄38（10～69）岁，低剂量化疗组78例，常规剂量化疗组139例。低剂量化疗组与常规剂量化疗组相比，4周完全缓解（CR）率（98.7％对97.0％，P＝0.766）及总CR率（100％对100％，P＝1.000）差异均无统计学意义。多因素分析显示，化疗剂量对无病生存率、总生存率无显著影响。而两组诱导化疗期间感染发生率（OR＝0.444，95％ CI 0.227～0.866，P＝0.017）、粒细胞缺乏持续时间（OR＝0.272，95％ CI 0.128～0.576，P＝0.001）、PLT<20×109/L持续时间（OR＝0.487，95％ CI 0.232～1.022，P＝0.057）及红细胞悬液输注量（OR＝0.309，95％ CI 0.147～0.651，P＝0.002）差异有统计学意义，低剂量组均显著低或短于常规剂量化疗组。结论对于Ph+ ALL患者，低剂量化疗联合TKI作为一线诱导治疗的疗效与常规剂量化疗相当，且安全性好。

The Impact of COVID-19 Vaccination on the Social Participation of Immunocompromised Persons - Results of a Multicenter Observational Study.

Immunocompromised persons are at an increased risk for a severe SARS-CoV-2 infection and their safety behaviors may influence their social participation. Vaccinated persons have a lower incidence of infection and severe disease when infected compared to non-vaccinated persons. Therefore, their behavior may change and their social participation may increase after a complete vaccination. The aim of this study was to explore social participation of immunocompromised persons before and after complete COVID-19 vaccination. Between March and September 2021, 274 immunocompromised participants were recruited. Survey data were collected at baseline and follow-up from 194 participants including the Index for the Assessment of Health Impairments [IMET], Patient Health Questionnaire-4 [PHQ-4], subjective health status and quality of life. At baseline, participants were not yet completely vaccinated. Complete vaccination was achieved prior to the follow-up questionnaire. IMET scores decreased significantly at follow-up, indicating a higher social participation after complete vaccination. PHQ-4, subjective health status and quality of life did not differ between baseline and follow-up. There were no significant differences across sociodemographic factors. Significant PHQ-4 differences were observed regarding the population size of the participants' home community. Social participation of immunocompromised persons in our study increased after COVID-19 vaccination. Therefore, social participation should be explored further, especially with regards to the impact of vaccination on groups with a high health risk.

Factors influencing Ralstonia pseudosolanacearum infection incidence and disease development in rose plants

AbstractGlasshouse experiments were conducted to study infection and disease development in rockwool‐grown rose plants inoculated with Ralstonia pseudosolanacearum. A R. pseudosolanacearum strain isolated from rose plants was more aggressive than strains from anthurium or curcuma. The three rose cultivars tested, Avalanche, Red Naomi, and Armando, differed in susceptibility. At 20°C, the rose strain caused hardly any symptoms over a 6‐week period, whereas at 28°C typical wilt symptoms were observed within 2 weeks after stem inoculation of Armando, the most susceptible cultivar. Inoculating roots with the rose strain resulted only in weak atypical symptoms. Nevertheless, inoculating roots of cv. Armando at a relatively low inoculum dose of 104 cfu/ml led to high densities in the base of stems in one out of two experiments. R. pseudosolanacearum occasionally spread from stem inoculated plants with symptoms in rockwool slabs. This limited spread resulted in a low infection incidence, and only of plants directly adjacent to the plants with symptoms.

FC057: Incidence of Infections in the Avacopan Group Versus Prednisone Group in Anca-Associated Vasculitis, Results from the Phase 3 Advocate Study

Abstract BACKGROUND AND AIMS Standard therapy for ANCA-associated vasculitis (AAV) includes glucocorticoids (GC), which are associated with increased infections. Avacopan is an orally administered selective inhibitor of the C5a receptor recently approved for treatment of AAV. The phase 3 ADVOCATE study tested daily avacopan as a substitute for a standard, scheduled, daily oral GC tapered regimen (all with standard background therapy), resulting in a 63% mean reduction in overall GC load for the avacopan group. At week 26, the avacopan group achieved a comparable remission rate to prednisone (72.3% versus 70.1%) and superior sustained remission at Week 52 (65.7% versus 54.9%; one-sided P = 0.0066) (1). The present analysis compared infections in avacopan and prednisone groups in the ADVOCATE trial. METHOD ADVOCATE, a phase 3, randomized, double-blind, controlled trial in 330 patients, evaluated the efficacy and safety of avacopan. AAV patients (new onset or relapsing disease) were randomized to receive avacopan 30 mg twice daily, or a standard 20-week oral prednisone taper, plus matching placebos. Both groups had background therapy of either cyclophosphamide (followed by azathioprine) or rituximab, and additional GC exposure from premedication for rituximab, from taper of pre-randomization GC, and as required per investigator judgment. Patients were on blinded study drug for 52 weeks. Infections occurring from first dose of blinded study drug through day 56 after last dose were analyzed. RESULTS Total mean GC use during the first 26 weeks of the study was 1073 mg with avacopan and 3193 mg with prednisone groups, and in the last 26 weeks, 296 and 489 mg, respectively. Infections were higher in the prednisone group than with avacopan: 291 events (prednisone) versus 233 (avacopan), with a 75.6% incidence (124/164) with prednisone versus 68.1% (113/166) with avacopan (Table 1). During the prednisone taper period (first 20 weeks), infection incidence was 54.9% in prednisone group versus 49.4% for avacopan, and after the first 20 weeks 52.4% in prednisone group versus 44.0% avacopan. Fewer patients in the avacopan group experienced serious AEs of infection (13.3%/25 events) versus prednisone group (15.2%/31 events); also serious opportunistic infections (3.6% versus 6.7%), life-threatening AEs of infection (0.6% versus 1.2%), and infections resulting in death (0.6% versus 1.2%) were fewer with avacopan (Table 1). No Neisseria meningitidis infections occurred in any patient in the trial. CONCLUSION In the ADVOCATE trial, the mean dose of GCs from all sources was 63% lower in the avacopan group than the prednisone group (1349 versus 3655 total mg, respectively). The avacopan group had a numerically lower incidence of infections, including serious, life-threatening, fatal and serious opportunistic infections compared with the prednisone group.

Orthopedic Surgery in Ambulatory Surgery Centers During the COVID-19 Pandemic: Low Incidence of Infection Among Patients, Surgeons, and Staff.

Background and objectiveThe coronavirus disease 2019 (COVID-19) pandemic has presented tremendous challenges to the healthcare systems worldwide. Consequently, ambulatory surgery centers (ASCs) have been forced to find new and innovative ways to function safely and maintain operations. We conducted a study at a large United States (US) private orthopedic surgery practice, where a universal screening policy and testing protocol for COVID-19 was implemented for patients and ASC personnel including surgeons, in order to examine the incidence of COVID-19 in patients scheduled for orthopedic surgery in ASC settings as well as the incidence among the surgeons and ASC personnel.MethodsThe universal screening protocol was implemented in the ASCs of the facility during the early stage of the pandemic for an eight-month period from April 28, 2020, to December 31, 2020. All ASC personnel including surgeons had their symptoms tracked daily and were rapid-tested every two weeks. All patients were screened and tested before they entered the ASC.ResultsA total of 70 out of 12,115 patients and 41 out of 642 ASC personnel tested positive for COVID-19, resulting in infection rates of 0.6% and 6.4%, respectively. Individual symptoms, age, the American Society of Anesthesiologists (ASA) scores, and comorbidities were documented, and no single factor was found to be common among positive (+) tests.ConclusionsThe implementation of universal screening and symptom-reporting procedures was associated with a very low rate of infections among ASC patients, staff, and surgeons, and it offers a reproducible framework for other facilities to continue to provide orthopedic outpatient operations in ASC settings during the ongoing iterations of the COVID-19 pandemic.

Implication of the emergence of the delta (B.1.617.2) variants on vaccine effectiveness.

IntroductionCOVID-19 vaccines have been developed to compact the current SARS-CoV-2 pandemic and have been administered to people all over the world. These vaccines have been quite effective in reducing the possibility of severe illness, hospitalization and death. However, the recent emergence of Variants of Concern specifically the delta variant, B.1.617.2, had resulted in additional waves of the pandemic.MethodsWe aim to review the literature to understand the transmission and disease severity, and determine the efficacy of the current COVID-19 vaccines. We searched Pubmed, Scopus, and Embase till August 4th 2021, and used the search terms “delta variant”, “vaccinations”,” breakthrough infections”, and “neutralizing antibody”. For the meta-analysis, 21 studies were screened in particular and five articles (148,071 cases) were included in the study, and only four were analyzed in the meta-analysis.ResultsIn this review, both in vitro and in vivo studies showed significant reductions in neutralization rates against delta variants for vaccinated individuals and convalescent patients with prior history of COVID-19. However, There was a lower incidence of infection with SARS-CoV-2 due to Delta variant was found after the second dose of Pfizer-BioNTech, Oxford-AstraZeneca and Moderna vaccines.ConclusionIn fully vaccinated individuals, symptomatic infection with the delta variant was significantly reduced, and therefore, vaccinations play an important role to assist the fight against delta variant.

385. SARS-CoV-2 Infections Among Military Personnel Deployed on the USNS COMFORT to New York City During the COVID-19 Pandemic and One-Year Follow-Up

BackgroundThe USNS COMFORT deployed to New York City to augment the inpatient health care capacity in March 2020. The aim of this study was to determine the prevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection among US Navy personnel upon return from deployment, and to identify incident cases of SARS-CoV-2 infection during 1 year of follow-up.MethodsCrewmembers, the majority of whom were health care workers (HCW), were enrolled following deployment, in May 2020. PCR results from symptomatic crewmembers during deployment, and Day 0 and Day 14 post-deployment screening swabs conducted on all crewmembers, per military order, were abstracted. A questionnaire and serum were collected on Day 14 post-deployment. SARS-CoV-2 infection was defined as a positive SARS-CoV-2 spike glycoprotein immunoglobulin G antibody (IgG) or PCR. COVID-19 related medical encounters, PCR and antibody testing results within 1 year following deployment were abstracted from the Military Health System Data Repository (MDR). There was adequate provision of personal protective equipment (PPE) in the hospital and the COVID-19 vaccine roll-out for HCW began in December 2020. ResultsOf the 1200 crewmembers, 449 were enrolled and completed the questionnaire and screening swabs, and 432 (96.2%) completed the Day 14 blood draw (Table 1). The cumulative prevalence of SARS-CoV-2 infection was 3.01% (13/432; 95% CI, 1.61%–5.09%). One of 17 subjects did not complete the blood draw and was PCR positive on Day 14. 433/449 (96.4%) had a PCR performed during the follow-up period (i.e. after the Day 14 post-deployment visit until Feb 2021), for HCW screening or symptomatic illness (median number of tests: 2 [IQR: 1, 2; range: 1,6]). 25 of 433 (5.8%) were PCR positive (Fig 1). 19 (76.0%) occurred in corpsmen, 23 (92.0%) were symptomatic and none were hospitalized. One asymptomatic re-infection occurred in a crewmember who was PCR negative and IgG positive at Day 14 post-deployment. Table 1. Characteristics of the overall cohort and by SARS-CoV-2 infection Figure 1. Number of PCR tests (bar graph) and positivity rate (red line) by month in 449 USNS COMFORT crewmembers during 1-year follow-up after return from deployment ConclusionThe post-deployment prevalence of SARS-CoV-2 infection was low. A high proportion of HCW underwent PCR testing during 1-year follow-up but a low incidence of infection was observed. This was likely from community transmission as nosocomial transmission was mitigated by adequate PPE and vaccine roll-out. Disclosures All Authors: No reported disclosures

591. Comparison of Fluconazole to Other Antifungal Agents in Allogeneic Hematopoietic Cell Transplant Recipients: A Meta-Analysis of Randomized Clinical Trials

BackgroundInvasive fungal infections (IFI) are adverse complications of allogeneic and autologous hematopoietic stem cell transplantation (HSCT) with significant mortality and morbidity. Randomized Controlled Trials (RCT) have addressed the optimal anti-fungal prophylaxis regimen. However, the consensus for an anti-fungal prophylaxis regimen has remained elusive. Hence, we performed a meta-analysis of currently available RCTs comparing the efficacy of fluconazole vs. other antifungal agents including voriconazole, micafungin, and itraconazole in the endpoint of preventing IFI.MethodsRandomized controlled trials were retrieved from PubMed, according to our inclusion criteria. The relative risk (RR), hazard risk (HR), and 95% confidence intervals (CI) were calculated. A random effect or fixed-effect model was used to calculate the pooled HR, based on heterogeneity. All statistical analyses were performed using RevMan software and R Core Team, and all p-values were two-tailed, and the significance level was 0.05.ResultsTen RCTs were selected involving 2654 pts. Our results showed fluconazole is statistically inferior to other agents that include voriconazole, micafungin, and itraconazole with regards to the endpoint of a lower incidence of IFI (RR: 1.05; 95%CI: 1.02, 1.08; p=0.0002, I2=5%). However, subgroup analysis showed no statistical difference between fluconazole vs. other agents to prevent breakthrough proven IFI (HR: 0.76; 95%CI: 0.47, 1.23; p=0.27, I2=0%). Our subgroup analysis further showed that other agent’s group might have a superior role in preventing aspergillus compared with fluconazole (HR: 0.64; 95%CI: 0.44, 0.94; p=0.02, I2=0%), but no significant advantages over fluconazole for candidiasis (HR: 0.96; 95%CI: 0.45, 2.07; p=0.92, I2=0%).Successful Rate Without Incidence of IFI Figure 1. Successful Rate Without Incidence of IFIProven IFI vs. Suspected IFI Figure 2. Proven IFI vs. Suspected IFICandidiasis vs. Aspergillus Figure 3. Candidiasis vs. AspergillusConclusionThis meta-analysis yield data that suggests fluconazole might be inferior to other agents in preventing IFI in all intent to treat patients undergoing HSCT. However, fluconazole is non-inferior in preventing proven IFI and candidiasis IFI based on our results. Thus, we continue to recommend fluconazole in selected patients who require anti-fungal prophylaxis. More RCTs are needed in the future to demonstrate the drug of choice for anti-fungal prophylaxis and address patient selection characteristics.Disclosures All Authors: No reported disclosures