Parenteral Treatment Research Articles

Novel Antibiotic-Irrigating Wound Protector Reduces Infectious Complications in Robot-Assisted Radical Cystectomy with Extracorporeal Urinary Diversion

ObjectiveTo determine whether use of an antibiotic-irrigating wound protector (AWP) reduces infectious complications after robotic radical cystectomy with extracorporeal urinary diversion (RCUD). MethodsA prospectively maintained bladder cancer database was queried for patients undergoing robotic RCUD at a tertiary referral center one year prior to implementing an AWP and one year after (2018–2020). All diversions were performed extra-corporally. 92 patients total. 46 consecutive patients using a traditional wound protector (TWP) and 46 consecutive with an AWP. Infections were classified as symptomatic urinary tract infection, blood stream infection, and surgical site infection. The incidence of infectious complications at 30- and 90-days were compared. ResultsBaseline patient characteristics between the 2 groups showed no statistically significant differences. The overall complication rate was 65.2% in the TWP group and 26.1% in the AWP group at 30-days, and 67.4% vs 30.4% at 90-days. Focusing on infections, the 30-day complication rate was 30.4% in the TWP group compared to 6.5% in the AWP group (P =.003). This pattern persisted at 90-days with 37.0% in the TWP group compared to 6.5% in the AWP group (P =.004). Most complications were symptomatic UTI and blood stream infections, 14/24 (58%), requiring parenteral antibiotic treatment. ConclusionWe provide preliminary data showing use of an AWP can reduce infectious complications after RCUD. While larger prospective studies are warranted, our findings are a significant step towards decreasing morbidity of an already highly morbid procedure.

On the question of parenteral treatment of "acute and chronic urticaria"

In this brief and incomplete communication, I feel it necessary to share the very satisfactory results I have obtained in the treatment of urticaria by injecting a combination of two substances: absolute alcohol and ichthyol.

Evaluation of the effect of antibiotics used during parenteral nutrition treatment on Candidemia.

Parenteral nutrition is an important risk factor for candidemia. In this risk analysis study, the effect of previous antibiotic administration apart from the length of hospital stay, duration of Parenteral nutrition treatment, and Candida score parameters on developing candidemia was evaluated in the non-neutropenic patients receiving Parenteral nutrition treatment. In this double center, retrospective, and cross-sectional study, the data of patients who received Parenteral nutrition treatment were collected. Patients with or without candidemia after the initiation of Parenteral nutrition treatment were compared in terms of demographic features, Candida score, length of hospital stay, duration of Parenteral nutrition treatment, and previous use of antibiotics. Then, predictor factors affecting the probability of candidemia during Candida growth time were determined by the Cox regression analysis. A total of 148 patients (59.5% males) were included and 16 (10.81%) of these had candidemia after initiation of parenteral nutrition treatment. The median (min-max) duration of parenteral nutrition treatment was 11 (4-72) days and the Candida growth time was 13 (7-29) days. Statistically significant differences were found between patients with or without candidemia groups in terms of length of hospital stay (p<0.001), duration of parenteral nutrition treatment (p<0.001), and Candida score (p<0.001). To determine the effect of these variables and antibiotics on candidemia, length of hospital stay [Hazard Ratio 1.030; p=0.021] and piperacillin-tazobactam (Hazard Ratio 5.626; p=0.030) were found significant and independent risk factors on the development of candidemia. There are some well-known risk factors including length of hospital stay, duration of Parenteral nutrition treatment, and Candida score; the potential impact of piperacillin-tazobactam administration should also be considered since they may be effective on the development of candidemia.

HEALTH OUTCOMES AND COSTS ASSOCIATED WITH ORAL TREPROSTINIL AND SELEXIPAG ONE YEAR INTO TREATMENT: A UNITED STATES CLAIMS DATABASE ANALYSIS IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION

TOPIC: Pulmonary Vascular Disease TYPE: Original Investigations PURPOSE: Previous comparisons of oral treprostinil (TRE) and selexipag (SLX) using real-world data have been limited to short duration follow-up periods or have used models to estimate healthcare costs. This analysis aims to characterize various outcomes and direct healthcare costs for pulmonary arterial hypertension (PAH) patients being treated with TRE or SLX 1-year into treatment. METHODS: A retrospective analysis was completed using the IBM® MarketScan® Research Databases from January 2014 to June 2019. Patients were required to have a pulmonary hypertension inpatient or outpatient medical claim identified by International Classification of Disease Codes (ICD-9-CM: 416.0, 416.8, 416.9; ICD-10-CM: I27.0, I27.20, I27.21, I27.29, I27.81, I27.83, I27.89, I27.9) plus a prescription claim for TRE or SLX. The index date was defined as the day of the first claim for TRE or SLX. Patients were ≥18 years old and required to have a PH medical claim in the 6-month pre-index, continuous health insurance enrollment 6 months pre-index and 12 months post-index. Adherence was defined as having a medication possession ratio (MPR) ≥80% and persistence was defined by continuous therapy in the 1-year follow-up period without a medication gap of ≥60 days. RESULTS: 120 patients in the TRE cohort and 155 patients in the SLX cohort met inclusion criteria. Patients were of similar age (TRE: mean [SD] = 57.0 [16.1] vs. SLX: 57.2 [13.5]), similar sex (TRE: 70% female vs. SLX: 77.4%) and had a similar Charlson Comorbidity Index (CCI) score (TRE: mean [SD] 3.5 [2.6] vs. SLX: 3.1 [2.0]). Concomitant PAH therapies received during the pre-index period were generally similar between cohorts, however, more patients on TRE compared to SLX (11.7% vs. 2.6%, p=0.003) transitioned from parenteral PAH treatment. In the 1-year following treatment, adherence and persistence were comparable: adherence was 83% for TRE and 81% for SLX (p=0.567) and persistence was 53% for TRE and 59% for SLX (p=0.373). Among the patients persistent on therapy at 1-year, median (IQR) annual pharmacy costs were $232,071 ($211,039-$256,402) for SLX compared with $107,511 ($45,647-$186,622) for TRE (p<0.01) representing 116% higher median annual pharmacy costs for SLX. A similar proportion within each group switched to parenteral prostacyclin therapy (TRE: 6.7% vs SLX: 5.2%, p=0.794) or inhaled prostacyclin therapy (TRE: 3.3% vs SLX: 3.2%, p=1.0) in the 1-year follow-up period. After adjusting for baseline differences between cohorts, total mean PAH-related healthcare costs (pharmacy + medical) in the 1-year follow-up period were $350,782 ($307,873-$394,849) for SLX compared to $229,564 ($198,791-$264,944) for TRE (p<0.05). CONCLUSIONS: Real-world claims data show similar utilization and outcomes for TRE and SLX in patients with PAH with notable differences in costs in the 1-year following treatment initiation. CLINICAL IMPLICATIONS: Cost differences between TRE and SLX should be considered when selecting oral prostacyclin therapies given the broader economic impact on the U.S. healthcare system as well as potential costs specific to health insurers, pharmacy-benefit managers, employers, and patients. DISCLOSURES: Employee relationship with United Therapeutics Please note: >$100000 by Peter Classi, source=Web Response, value=Salary Consultant relationship with United Therapeutics Please note: 2020-current Added 04/27/2021 by Bonnie Dean, source=Web Response, value=Grant/Research Support Employee relationship with United Therapeutics Please note: 2017 to Present Added 04/27/2021 by Alex DeRuiter, source=Web Response, value=Salary Employee relationship with Xcenda, LLC Please note: 01/04/2020 Added 04/30/2021 by Henry Lee, source=Web Response, value=Salary Employee relationship with United Therapeutics Corporation Please note: >$100000 by Kellie Morland, source=Web Response, value=Salary Employee relationship with Xcenda LLC Please note: Jan 1, 2020 Added 04/27/2021 by Dana Stafkey-Mailey, source=Web Response, value=UT provided Xcenda Fin Support Employee relationship with United Therapeutics Corporation Please note: 11 Months Added 04/27/2021 by Benjamin Wu, source=Web Response, value=Salary

Changes in Antibiotic Treatment for Children With Lyme Meningitis 2015-2020.

Although ceftriaxone has been the first-line treatment of Lyme meningitis, the 2020 Infectious Disease Society of America, American College of Rheumatology, and American Academy of Neurology guideline recommends either doxycycline or ceftriaxone. Our objective was to explore recent trends in enteral antibiotic treatment of children with Lyme meningitis. Using International Classification of Diseases, 10th Revision codes for case identification, we performed a multicenter retrospective study of patients ≤21 years of age presenting to a pediatric hospital contributing to the Pediatric Health Information System who were diagnosed with Lyme meningitis from 2015 to 2020. Our primary outcome was treatment with parenteral antibiotics, defined by either a procedure code for indwelling catheter placement or >7 days of inpatient parenteral Lyme disease-specific therapy. To examine trends over the study period, we used a generalized estimating equation, with parenteral antibiotics as the dependent variable and study year as the independent variable, adjusted for patient age, sex, race, ethnicity, and insurance status clustered by hospital. We identified 239 patients with Lyme meningitis treated at 24 participating centers. Overall, 48 (20.0%) were treated with parenteral antibiotics, with a declining rate over the study period (43.8% in 2015 to 8.9% in 2020). After adjustment, the odds of treatment with a parenteral antibiotic decreased over the study period (adjusted odds ratio 0.57; 95% confidence interval 0.41-0.80). Parenteral antibiotic treatment of children with Lyme meningitis has been on the decline in advance of the published clinical guideline. Carefully designed comparative effectiveness studies are needed to examine the effect of oral versus parenteral treatment regimens on clinical outcomes.

Recommendations for the care of patients with diabetes mellitus with risk factors or established cardiovascular disease and SARS-CoV-2mellitus con factores de riesgo o enfermedad cardiovascular establecida y SARS-CoV-2.

A review is carried out to examine the risk of patients suffering from diabetes mellitus in the context of general morbidity and mortality and related to infection by SARS-CoV-2. Likewise, the general recommendations for food and the prevention of comorbidities that most these patients suffer most frequently are also studied. Finally, a review of the pharmacological recommendations on both oral and parenteral treatment in the outpatient, in hospitalization and in critical states infected with SARS-CoV-2 is made.

One-third of people who inject drugs are at risk of incomplete treatment for Staphylococcus aureus bacteraemia: a retrospective medical record review

Staphylococcus aureus bacteraemia (SAB) is often a complication of injecting drug use, and is associated with high morbidity and mortality. This article reports the first audit of inpatient parenteral treatment of SAB completion among people who inject drugs (PWID) in Australia. Of 198 patients admitted with SAB, 106 were analysed. Twelve PWID had an inpatient stay <14 days compared with seven non-PWID (34% vs 10%; P=0.002). Sixteen PWID experienced discharge against medical advice compared with zero non-PWID (46% vs 0%; P<0.001). Re-admission to hospital within 28 days was 2.5 times greater among PWID than non-PWID (31% vs 15%; P=0.026). Methadone dose <60 mg/day was associated with premature discharge in opioid-dependent PWID receiving methadone (n=21, 100% vs 31%; P=0.012).

PCO-014 - Parenteral and oral anticoagulant treatment for hospitalized and post-discharge patients with COVID-19: A systematic review

PCO-014 - Parenteral and oral anticoagulant treatment for hospitalized and post-discharge patients with COVID-19: A systematic review

Treatment of UTIs in Infants

Urinary tract infections (UTIs) are the most common bacterial infections in infants <2 months of age. However, there are no clear guidelines on the appropriate duration of antibiotics in this age group. In this living systematic review, we compared different durations of parenteral antibiotics (≤3 vs >3 days) in neonates and young infants (<2 months) with UTIs. The secondary objective was to compare different durations of total antibiotic courses (≤10 vs >10 days). MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science, Literatura Latino-Americana e do Caribe em Ciências da Saúde, Google Scholar, and gray literature, up to March 2, 2021. Citations were screened in triplicate by using a crowdsourcing methodology, to identify randomized controlled trials and observational studies. Data were extracted by 2 crowd members and verified by an expert investigator. Outcomes were pooled via random-effects models. A total of 10 334 citations were screened, and 12 eligible studies were identified. A total of 59 of 3480 (1.7% [95% confidence interval (CI): 1.3% to 2.2%]) infants had a UTI recurrence within 30 days after short parenteral treatment (≤3 days), and 47 of 1971 (2.4% [95% CI: 1.8% to 3.2%]) after longer courses. The pooled adjusted odds ratio for UTI recurrence with a short versus long duration of parenteral antibiotics was 1.02 (95% CI: 0.64 to 1.61; P = .95; n = 5451). A total of 5 studies assessed the risk of recurrence on the basis of the total duration of antibiotics (≤10 vs >10 days) with no significant differences (pooled odds ratio: 1.29 [95% CI: 0.45 to 3.66; P = .63; n = 491). On the basis of retrospective studies and Grading of Recommendations, Assessment, Development, and Evaluation level low evidence, short and long duration of parenteral antibiotics were associated with a similar risk of UTI recurrence in infants <2 months.

Direct Oral Anticoagulants as Successful Treatment of Heparin-Induced Thrombocytopenia: A Parisian Retrospective Case Series.

Background: Heparin-induced thrombocytopenia (HIT) is a prothrombotic life-threatening disorder caused by an adverse reaction to heparin exposure. In this context, it is imperative to stop heparin immediately and to replace it by a non-heparin anticoagulant therapy. Despite their advantages, the use of direct oral anticoagulants (DOACs) is only emerging for HIT treatment, and their use remains rare.Objective: To improve our knowledge on the emerging role of DOACs as treatment of HIT and give an overview of our local practices in this context.Patients/Methods: This is a multi-centric retrospective case series of HIT patients referred to our Parisian pharmacovigilance network and treated with DOACs.Results: We report the cases of seven patients from four healthcare centers, diagnosed with HIT (4T score ≥ 4, positive anti-PF4/heparin immunoassay and positive serotonin-release assay) and treated with DOACs. After a few days on substitutive parenteral treatment (n = 6) or directly at HIT diagnosis (n = 1), these patients were treated with either rivaroxaban (n = 6) or apixaban (n = 1) during acute HIT phase. Mean time to platelet count recovery after heparin discontinuation was 3.3 days (range 3–5). No patient experienced major or clinically relevant non-major bleeding or thrombosis that could be related to DOAC treatment during follow-up.Conclusions: Our cases studies are consistent with recent guidelines credit to the potential and safe use of DOAC during acute HIT in clinically stable patients.

Immune Responses and Efficacy of Brucella Abortus Strain RB51 in Bison After Delivery in a Dry Dart Formulation or by Parenteral Inoculation.

Bison (Bison bison) heifer calves (n = 32) were randomly assigned to control or vaccination with 1010 colony-forming units of Brucella abortus strain RB51 (RB51) vaccine by single or boostered parenteral delivery, or by surgical implantation of a dry dart formulation (n = 8/trt). Serum and/or peripheral blood mononuclear cells (PBMC) were obtained at 0, 4, 8, 13, 16, 21, and 24 wks after initial vaccination and at 0, 4, 8, 12, 15, 22, and 27 wks after booster vaccination to characterize humoral and cellular immune responses to RB51. Bison in both RB51 vaccination treatments demonstrated greater (P < 0.0001) serum humoral responses when compared to non-vaccinates, with parenteral vaccinates demonstrating greater (P < 0.01) responses when compared to mean responses of bison inoculated with the dry dart. Only the booster vaccinated treatment demonstrated greater (P < 0.0001) humoral responses than control bison in samples collected after re-inoculation. At 4, 8, 12, 16, and 24 wks after initial vaccination, PBMC from parenteral RB51 vaccinates demonstrated greater proliferative responses to RB51 when compared to responses of control animals. In comparison, bison inoculated with the RB51 dry dart did not demonstrate greater (P > 0.05) proliferative responses when compared to responses of non-vaccinates. Bison were pasture bred and pregnant animals experimentally challenged in mid-gestation with 107 CFU of B. abortus strain 2,308. Bison in parenteral vaccination treatments had reduced (P < 0.05) abortions and infection in uterine and fetal samples as compared to non-vaccinated bison, with booster vaccinates tending to have the lowest colonization (CFU/gm) in tissues. In comparison, the dry dart formulation did reduce abortion (P < 0.05) but not infection (P > 0.05) in most tissues when compared to non-vaccinated bison. The results of this study reaffirm the efficacy of boostered parenteral vaccination of bison with RB51 in preventing brucellosis. Our data also suggests that the novel dry dart RB51 formulation does not induce sufficient efficacy in bison after a single inoculation.

Cross-sectional analysis of emergency hypoglycaemia and outcome predictors among people with diabetes in an urban population.

Out-of-hospital hypoglycaemia is a common complication for individuals with diabetes mellitus and represents a significant burden to emergency medical services (EMS). We aim to identify the factors associated with receiving parenteral treatment and hospital conveyance. We retrospectively analysed a 6-month data set of all London EMS hypoglycaemia. Individuals with a known diabetes diagnosis were included in our analysis and stratified as either having type 1 diabetes or type 2 diabetes. A total of 2862 incidents occurred within the area served by London Ambulance Service between January and June 2018. Fifty percent of incidents required parenteral treatment (intravenous glucose or intramuscular glucagon) and were conveyed to hospital. A higher arrival of blood glucose, intact consciousness and receiving oral glucose treatment were all negative predictors for requiring parenteral therapy. Forty-three percent of incidents were labelled as 'hypoglycaemia' by the EMS call handler, and greater odds of hospitalisation were observed among incidents that received parenteral treatment (OR 2.52 [95% CI 1.46, 4.33] p<0.01) and individuals with type 2 diabetes (OR 2.67 [95% CI 1.52, 4.71] p<0.01). Repeated callouts from 2% (n=50) of individuals accounted for 10% (286) of all incidents attended, and 56.4% of individuals attended by EMS on more than one occasion had type 1 diabetes. Severe hypoglycaemia requiring emergency service attendance remains common, as does the requirement for parenteral therapy and conveyance to hospital. Early intervention, education and improved accessibility to risk prevention strategies may reduce the necessity for emergency parenteral treatment and hospitalisation, especially among individuals suffering from recurrent hypoglycaemia and high-risk individuals with type 2 diabetes.

Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: study protocol of a randomized multi-center phase III trial\u2014AkniPro 2

BackgroundA previously performed phase III trial on 112 subjects investigating prophylactic nimodipine treatment in vestibular schwannoma (VS) surgery showed no clear beneficial effects on preservation of facial and cochlear nerve functions, though it should be considered that protection of facial nerve function was the primary outcome. However, the risk for postoperative hearing loss was halved in the nimodipine group compared to the control group (OR 0.49; 95% CI 0.18–1.30; p = 0.15). Accordingly, this phase III extension trial investigates the efficacy and safety of prophylactic nimodipine for hearing preservation in VS surgery.MethodsThis is a randomized, multi-center, two-armed, open-label phase III trial with blinded expert review and two-stage with interim analysis. Three hundred thirty-six adults with the indication for microsurgical removal of VS (Koos I–IV) and serviceable preoperative hearing (Gardner-Robertson scale (GR) 1–3) are assigned to either the therapy (intravenous nimodipine 1–2 mg/h from the day before surgery until the fifth postoperative day and standard of care) or the control group (surgery only and standard of care). The primary endpoint of the trial is postoperative cochlear nerve function measured before discharge according to GR 1–3 versus GR 4–5 (binary). Hearing function will be determined by pre- and postoperative audiometry with speech discrimination, which will be evaluated by a blinded expert reviewer. Furthermore, patient-reported outcomes using standardized questionnaires will be analyzed.DiscussionProphylactic parenteral nimodipine treatment may have a positive effect on hearing preservation in VS surgery and would improve patient’s quality of life. Further secondary analyses are planned. Except for dose-depending hypotension, nimodipine is known as a safe drug. In the future, prophylactic nimodipine treatment may be recommended as a routine medication in VS surgery. VS can be considered as an ideal model for clinical evaluation of neuroprotection, since hearing outcome can be classified by well-recognized criteria. The beneficial effect of nimodipine may be transferable to other surgical procedures with nerves at risk and may have impact on basic research.Trial registrationEudraCT 2019-002317-19, DRKS00019107. 8th May 2020.

Needle aspiration of lateral neck abscess in children: A simple and effective treatment

BackgroundCervical abscesses frequently occurred in pediatric patients. Surgical drainage is currently recommended in the cases not responding to medical therapy. Needle aspiration may represent a simple, effective and minimally invasive treatment for acute neck suppuration in selected cases. ObjectiveTo evaluate the effectiveness of needle aspiration in the treatment of cervical abscesses in pediatric age as an alternative to surgical drainage. MethodsFrom November 2013 to November 2019, at the ENT Department of the “Bambino Gesù" Pediatric Hospital, Rome, we treated 47 children with cervical abscess by performing aspiration with a 19 G needle in wakefulness after applying local anesthetic. Parenteral antibiotic treatment was associated with all patients both before and after treatment. ResultsComplete regression of the abscess occurred in 46 children with no evidence of recurrence in the follow-up period. Surgical drainage was required in only one patient due to the lack of resolution of the abscess episode. No complications such as hematomas or hypertrophic scars were found in any patient. ConclusionsOur results confirm the effectiveness of needle aspiration in the treatment of cervical abscesses in children as an alternative to surgical drainage.

Small bowel obstruction caused by intrauterine device infection.

A 39-year-old previously healthy woman was referred to our emergency department by a primary care doctor on suspected to be acute enteritis, complaining of fever, anorexia, lower abdominal pain, and frequent diarrhea. The day after admission, although frequent diarrhea stopped, the abdominal distension worsened. An abdominal radiograph revealed several dilated loops of the small bowel, suggested that small bowel obstruction (SBO) had developed. White blood cell count and c-reactive protein were markedly increased, and abdominal contrast-enhanced computed tomography scan showed localized severely edematous bowel mucosa, increased adipose tissue concentration in the pelvis, and a beaded low absorption area in the uterus. Gynecological examination revealed the presence of a pus-filled plastic intrauterine device (IUD) in the uterus. The patient confided that she had sex with her husband 2 days before the onset of symptoms. A diagnosis of SBO due to pelvic peritonitis caused by IUD infection during sexual activity was made. The SBO was cleared in 12days with fasting, peripheral parenteral nutrition, antibiotic treatment, and insertion of an ileus tube. This case reminds us that it needs to consider disorders associated with the uterine appendages, in women of reproductive age with lower abdominal pain.

Comparison of Antimicrobial Treatment Incidence Quantification Based on Detailed Field Data on Animal Level with the Standardized Methodology of the European Medicines Agency in Veal Calves, Switzerland, 2016-2018.

Precise quantification of antimicrobial treatment incidence (TI) is crucial for benchmarking. Two widespread methods for treatment incidence quantification were compared for agreement. Field data were obtained from 38 veal farms from 2016 to 2018 (1905 calves, 1864 treatments). Calculation of TIswiss for calves was based on detailed treatment records using pharmacokinetic values from the Swiss Veterinary Medicines Compendium. The method published by the European Medicines Agency was used to calculate TI in defined daily doses (TIDDD). For each calf and treatment, TIswiss and TIDDD were calculated on level of the antimicrobial class, drug, application route, and farm. The quotient (Q) of TIswiss and TIDDD was calculated. Divergence in results between the two methods of ≤25% was arbitrarily set as good agreement. The agreement between TIswiss and TIDDD was mostly good. On class level, good agreement was observed for treatments representing 71.5% of the TIDDD, and 74.5% of the total TIDDD on drug level. Poor agreement was mainly observed for tylosin and sulfadimidine. The agreement was better for parenteral than for oral treatments (81.6% vs. 72.3%). For practically orientated calculation on farm level, good agreement was observed (77.5% of the TIDDD). The TIDDD method showed mostly good agreement, especially for parenteral treatments.

Economic Analysis of Posaconazole Prophylaxis in Patients with Acute Myeloid Leukemia Undergoing Remission Induction Chemotherapy from a Hospital Management Perspective

▪IntroductionInvasive fungal infections (IFI) are an important and trending causes of mortality in patients with acute leukemia. Especially during the remission induction, as well as stem cell transplantation, the patients bear the highest risk of IFI due to the prolonged severe neutropenia, long term exposure to broad spectrum antibiotics and cytotoxic chemotherapy.In a meta analysis of primary antifungal prophylaxis (PAT) in patients with malignancy receiving cytotoxic treatment and/or stem cell transplantation, antifungal prohylaxis was related with dramatic decrease in infection related mortality and decreased IFI. In another meta analysis focusing on prophylaxis with mould-active agents or fluconazole in hematologic malignancies has reported a significant decrease in IFI proven or probable, IFI related mortality and also with a concern, increased risk of adverse effects in the mould-active receiving group.Patients and Methods225 patients who have been diagnosed with acute myeloid leukemia (AML) and undergoing intensive treatment (idarubicin 12mg/m2 for three days and cytarabin 100mg/m2 24 h infusion for 7 days) for remission induction have been enrolled in the study in a retrospective manner. Direct health expenses like days of hospitalization, number of CT scans for thorax, development of complications, number of platelet apheresis infusions, mortality during remission induction treatment and total inpatient hospital costs. The benefits included cost reductions after adoption of primary antifungal prophylaxis.Results124 patients were male (55,4%) while 100 were female (44,6%). 90 patients received prophylactic treatment during remission induction therapy (40,2%). 43 patients died during remission induction therapy (19,2%). Mean number of thorax CT scans during remission induction was 1,73 (0-6). Mean number of days for hospitalization was 29,36 (14-88) days. Mean number of units of transfused thrombocyte apheresis was 9,9 (0-43) units. Mean cost of whole remission induction treatment was 9.151,6 (2.872,6-20.483,3) US dolars. Within patients who are not on PAT, 116 patients (86,5%) were treated with an intravenous antimould antifungal treatment while 5 of the patients on PAT (5,5%) received parenteral antimould antifungal treatment, 4 of which were related with neutropenic enterocolitis (p<0.005). 32 of the patients who are not on PAT died during remission induction (23,88%) while 11 of the patients who are on PAT died during remission induction (12,22%) (p=0.021). Mean days of hospitalization for remission induction treatment was 22,61 days for patients on PAT and 33,89 days for patients who are not on PAT (p<0.005). In patients on PAT, mean number of transfused platelet units was 6 (0-9) while 12,51 (4-43) units for patients who are not on PAT (p<0.005). When grouped as paients who are and who are not on PAT, there were significant difference between groups regarding total days of hospitalization, number of transfused platelet apheresis units, number of CT scans for thorax, death during remission induction and total cost of remission induction treatment in favor of patients on PAT. All significant data were analyzed with logistic regression analysis and observed as statistically significant. Results were summarized in Table.DiscussionIn Turkey, social security covers all the treatment for malignancies and complications, with rules and statements that lead the clinicians for decisions. Health Application Communiqué regulates the practice for reimbursement and since 2010, antimould antifungal agents are approved for prophylaxis in patients with AML who are undergoing remission induction therapy or patients undergoing hematopoietic stem cell transplantation. According to the physicians' or center's practices, PAT may be used and reimbursed.In our study, oral suspension form of posaconazole was effective to prevent IFI with a significant decrease in mortality during remission induction treatment. Likewise, PAT with posaconazole was observed to be cost-beneficial regarding the number of CT scans for thorax, number of platelet transfusion and over all costs of hospitalization for remission induction treatment. With its limitations regarding adherence as oral suspension form, tablet form may overcome these limitations. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Pharmacokinetics and pharmacodynamics of azithromycin in severe malaria bacterial co-infection in African children (TABS-PKPD): a protocol for a Phase II randomised controlled trial

Background: African children with severe malaria are susceptible to Gram-negative bacterial co-infection, largely non-typhoidal Salmonellae, leading to a substantially higher rates of in-hospital and post-discharge mortality than those without bacteraemia. Current evidence for treating co-infection is lacking, and there is no consensus on the dosage or length of treatment required. We therefore aimed to establish the appropriate dose of oral dispersible azithromycin as an antimicrobial treatment for children with severe malaria and to investigate whether antibiotics can be targeted to those at greatest risk of bacterial co-infection using clinical criteria alone or in combination with rapid diagnostic biomarker tests. Methods: A Phase I/II open-label trial comparing three doses of azithromycin: 10, 15 and 20 mg/kg spanning the lowest to highest mg/kg doses previously demonstrated to be equally effective as parenteral treatment for other salmonellae infection. Children with the highest risk of bacterial infection will receive five days of azithromycin and followed for 90 days. We will generate relevant pharmacokinetic data by sparse sampling during dosing intervals. We will use population pharmacokinetic modelling to determine the optimal azithromycin dose in severe malaria and investigate azithromycin exposure to change in C-reactive protein, a putative marker of sepsis at 72 hours, and microbiological cure (seven-day), alone and as a composite with seven-day survival. We will also evaluate whether a combination of clinical, point-of-care diagnostic tests, and/or biomarkers can accurately identify the sub-group of severe malaria with culture-proven bacteraemia by comparison with a control cohort of children hospitalized with severe malaria at low risk of bacterial co-infection. Discussion: We plan to study azithromycin because of its favourable microbiological spectrum, its inherent antimalarial and immunomodulatory properties and dosing and safety profile. This study will generate new data to inform the design and sample size for definitive Phase III trial evaluation. Registration: ISRCTN49726849 (27th October 2017).

The effect of short term peripheral parenteral nutrition on treatment outcomes and mortality in critically ill pediatric canine patients

BackgroundPeripheral parenteral nutrition (PPN) is increasingly considered as an alternative to central parenteral nutrition (CPN) given the higher cost and more frequent clinical complications associated with the latter. However, the assessment of potential risks and benefits of PPN in critically ill pediatric canine patients has not been extensively performed. In this study, we aimed to explore the effect of short-term, hypocaloric PPN on weight loss, length of hospital stay, the incidence of complications, adverse effects, and mortality in critically ill pediatric canine patients.ResultsBetween August 2015 and August 2018, a total of 59 critically ill pediatric canine patients aged from 1 to 6 months admitted at the Veterinary Sciences Research Institute of the Autonomous University of Baja California were included in this non-randomized clinical trial. Canine pediatric patients were initially allocated to 3 groups: 11 in group 1 receiving parenteral nutrition (PN) supplementation equivalent to 40% of the resting energy requirement (RER), 12 in group 2 receiving supplementation of 50% of the RER, and 36 in group 3 receiving no PN supplementation. After establishing that there was no significant difference between 40 and 50% of PN supplementation, these groups were not separated for downstream analysis.Similar lengths of hospital stays were noted among study subjects who received PN supplementation and those who did not (4.3 ± 1.5 vs. 5.0 ± 1.5, days, p = 0.097). No metabolic-, sepsis- or phlebitis-related complications were observed in any animal in the PPN supplemented group. Higher mortality (19.4% vs. 0%, p = 0.036), and a greater percentage of weight loss (9.24% vs. 0%, p < 0.001) were observed in patients who received no supplementation.ConclusionEven though short-term, hypocaloric PPN did not reduce the length of hospital stay, it was associated with lower mortality and resulted in mitigation of weight loss. In contrast to previous studies evaluating central and peripheral parenteral nutrition protocols, we observed a lower frequency of metabolic, septic, and phlebitis complications using a 40–50% parenteral nutrition treatment. The parenteral nutrition therapeutic intervention used in our study may reduce PN-related adverse effects and promote a favorable disease outcome in critically ill canine patients. Larger studies will be needed to confirm these observations.

Achievements in Thermosensitive Gelling Systems for Rectal Administration.

Rectal drug delivery is an effective alternative to oral and parenteral treatments. This route allows for both local and systemic drug therapy. Traditional rectal dosage formulations have historically been used for localised treatments, including laxatives, hemorrhoid therapy and antipyretics. However, this form of drug dosage often feels alien and uncomfortable to a patient, encouraging refusal. The limitations of conventional solid suppositories can be overcome by creating a thermosensitive liquid suppository. Unfortunately, there are currently only a few studies describing their use in therapy. However, recent trends indicate an increase in the development of this modern therapeutic system. This review introduces a novel rectal drug delivery system with the goal of summarising recent developments in thermosensitive liquid suppositories for analgesic, anticancer, antiemetic, antihypertensive, psychiatric, antiallergic, anaesthetic, antimalarial drugs and insulin. The report also presents the impact of various types of components and their concentration on the properties of this rectal dosage form. Further research into such formulations is certainly needed in order to meet the high demand for modern, efficient rectal gelling systems. Continued research and development in this field would undoubtedly further reveal the hidden potential of rectal drug delivery systems.