Infectious Episodes In Patients Research Articles

The relationship between oral diseases and infectious complications in patients under dialysis.

Association was investigated between oral health before dialysis and the incidence of systemic infections during dialysis. We hypothesized that low-grade systemic inflammation caused by poor oral health associates with infectious episodes in patients on dialysis, despite earlier eradication of oral infection foci. A total of 117 patients (46 with peritoneal and 71 with hemodialysis) were examined and treated at predialysis stage and followed up during dialysis. Number of infection episodes and microorganisms cultured from blood and peritoneal fluid were analyzed. Number of teeth, periodontal inflammatory burden, and total dental index scores were assessed, and salivary matrix metalloproteinase 8, triggering receptor on myeloid cells 1, peptidoglycan recognition protein 1 (PGLYRP1), and interleukin-1β were measured. In hemodialysis, 134 infection episodes were recorded, while peritoneal dialysis group had 77 peritonitis episodes. Culture-negative samples were 69% in hemodialysis and 23% in peritoneal dialysis group. Staphylococci were the most frequently associated microorganisms. Infections during dialysis did neither associate with oral health parameters nor associate with salivary inflammatory biomarkers, except for PGLYRP1, which associated with number of infection episodes during hemodialysis (p=.046). A number of infection episodes during hemodialysis were associated with salivary PGLYRP1 but not the other salivary markers or oral infection markers.

An Optimal Approach for Fluoroquinolone Garenoxacin Prophylaxis in Patients with Hematological Malignancies and Chemotherapy-induced Neutropenia

Antibiotic prophylaxis such as that with fluoroquinolone reportedly reduces infectious episodes in patients receiving chemotherapy regimens with the risk of febrile neutropenia. However, optimum patient characteristics, the timing of initiation, and antibiotics for prophylactic treatments have yet to be identified. We herein conducted a single-arm monocenter clinical study to elucidate the therapeutic profiles of fluoroquinolone garenoxacin prophylaxis for patients with hematological malignancies (HMs). Fever was not present for the duration of chemotherapyinduced neutropenia in 29 (43.9%) out of 66 patients. A shorter duration of prophylaxis until chemotherapy-induced neutropenia had a more potent effect on delaying febrile episodes, even in patients with fever. Excessive neutropenia (minimum zero neutrophils/l) negatively affected prophylactic effects. Garenoxacin accounted for 4.5% of the minor adverse events observed such as mild renal damage and skin reactions. Therefore, the study suggests that the initiation of garenoxacin prophylaxis from the introduction of neutropenia could be an effectual strategy for preventing chemotherapy-induced febrile episodes in HM patients with moderate neutropenia.

Patterns of infection and infection-related mortality in patients with steroid-refractory acute graft versus host disease.

This study aimed to characterize the incidence, etiology and outcome of infectious episodes in patients with steroid refractory acute GvHD (SR-GvHD). The cohort included 127 adults treated with inolimomab (77%) or etanercept (23%) owing to acute 2-4 SR-GvHD, with a response rate of 43% on day +30 and a 4-year survival of 15%. The 1-year cumulative incidences of bacterial, CMV and invasive fungal infection were 74%, 65% and 14%, respectively. A high rate (37%) of enterococcal infections was observed. Twenty patients (15.7%) developed BK virus-hemorrhagic cystitis and five percent had an EBV reactivation with only one case of PTLD. One-third of long-term survivors developed pneumonia by a community respiratory virus and/or encapsulated bacteria, mostly associated with chronic GvHD. Infections were an important cause of non-relapse mortality, with a 4-year incidence of 46%. In multivariate analysis, use of rituximab in the 6 months before SCT (hazard ratio; HR 4.2; 95% confidence interval; CI 1.1-16.3), severe infection before SR-GvHD onset (HR 5.8; 95% CI 1.3-26.3) and a baseline C-reactive protein >15 UI/mL (HR 2.9; 95% CI 1.1-8.5) were associated with infection-related mortality. High rates of opportunistic infections with remarkable mortality warrant further efforts to optimize long-term outcomes after SR-GvHD.

Sub-lingual administration of a polyvalent mechanical bacterial lysate (PMBL) in patients with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD spirometric classification: A multicentre, double-blind, randomised, controlled, phase IV study (AIACE study: Advanced Immunological Approach in COPD Exacerbation)

Polyvalent mechanical bacterial lysates (PMBLs) have been shown to reduce the number of infectious episodes in patients with recurrent infections of the respiratory tract. Some previous investigations have also shown the effectiveness of PMBLs in reducing exacerbations of chronic obstructive pulmonary disease (COPD). The AIACE study, which was developed according to criteria of evidence-based medicine, evaluated whether the administration of PMBLs to COPD patients, in addition to the recommended treatment, was able to reduce the number of exacerbations by 25%. Two hundred eighty-eight patients with moderate to very severe COPD were recruited and randomly assigned to either placebo or PMBLs. The placebo or PMBLs were administered according to the standard scheme. The primary outcome of the study was not achieved. However, the number of days with fever (21 days per year versus 40.15; p < 0.001), the days of hospitalisation (65 days vs 162 days; p < 0.001), the interval between the first and second exacerbations (123.89 days vs 70.36; p = 0.03) and the number of days in poor health (109 days/year vs 171 days/year; p < 0.001) were significantly better in the PMBL group than in the placebo group. In conclusion, the results of this trials showed that Ismigen, in addition to guideline-suggested treatment, could not significantly reduce the number of exacerbations in the considered population; nevertheless, the secondary outcome results demonstrated potential benefits of this compound for relevant clinical outcomes.

Clinical efficacy and tolerability of an immune- stimulant* constituted by inactivated bacterial bodies in the prophylaxis of infectious episodes of airways: a double blind, placebo-controlled, randomized, multicentre study

&#x0D; &#x0D; &#x0D; &#x0D; Background: (Buccalin®) is a Bacterial Lysates (BL) that belongs to a family of immune-stimulators, developed more than 30 years ago and it still has a role in the prophylaxis of Recurrent Respiratory Tract Infections (RRTI). However, original studies were conducted with an approach that does not seem to be aligned with the present methodologies. In addition, concomitant therapies substantially improved in the last decades. These two reasons strongly suggested to update our knowledge on the capacity of this bacterial lysate (Buccalin®) to reduce the number of days with infectious episodes in patients with RRTI.&#x0D; Methods: A double blind, placebo-controlled, randomized, multicentre study was programmed (EudraCT code: 2011-005187-25). The reduction of the number of days with infectious episodes (IE) was the primary endpoint. Secondary endpoints were the number of IE, the use of concomitant drugs, the efficacy on signs and symptoms of RRTI and the safety of the drug. Patients were treated according to the registered schedule and were followed up for a period of 6 months.&#x0D; Results: From a cohort of 188 patients eligible for the study, 90 were included in the active group and 88 in the placebo group. The study was completed in 170 patients. A significant reduction of the number of days with IE was observed (6.57 days in the active group and 7.47 in the placebo group). Secondary endpoints were only partially achieved. No virtual adverse events related to the treatment were recorded.&#x0D; Conclusion: The administration of Buccalin® in patients with RRTI had the capacity to significantly reduce the number of days with IE in a multicentre, randomized, placebo controlled, clinical study. The treatment was safe. Of note, all patients were free to be treated with the best concomitant therapies. In these conditions, the positive results observed demonstrated that this bacterial lysate has maintained its capacity of reducing the days with infections in patients with RRTI, also in association to the concomitant therapies available nowadays.&#x0D; &#x0D; &#x0D; &#x0D;

The bacterial lysate Lantigen B reduces the number of acute episodes in patients with recurrent infections of the respiratory tract: The results of a double blind, placebo controlled, multicenter clinical trial

Studies in the 1970s and 1980s reported that bacterial lysates (BL) had a prophylactic effect on recurrent respiratory tract infections (RRTI). However, controlled clinical study procedures have evolved substantially since then. We performed a trial using updated methods to evaluate the efficacy of Lantigen B®, a chemical BL. This double blind, placebo controlled, multi-center clinical trial had the primary objective of assessing the capacity of Lantigen B to significantly reduce the total number of infectious episodes in patients with RRTI. Secondary aims were the RRTI duration, the frequency and the severity of the acute episodes, the use of drugs and the number of missed workdays. In the subgroup of allergic patients with RRTI, the number of allergic episodes (AE) and the use of anti-allergic drugs were also evaluated. One hundred and sixty patients, 79 allocated to the treated group (TG) and 81 to the placebo group (PG), were enrolled; 30 were lost during the study and 120 (79 females and 38 males) were evaluated. The PG had 1.43 episodes in the 8-months of follow-up while the TG had 0.86 episodes (p=0.036). A similar result was observed in the allergic patients (1.80 and 0.86 episodes for the PG and the TG, respectively, p=0.047). The use of antibiotics was reduced (mean 1.24 and 2.83 days of treatment for the TG and the PG). Logistic regression analysis indicated that the estimated risk of needing antibiotics and NSAIDs was reduced by 52.1 and 30.6%, respectively. With regard to the number of AE, no significant difference was observed between the two groups, but bronchodilators, antihistamines and local corticosteroids were reduced by 25.7%, 56.2% and 41.6%, respectively, in the TG. Lantigen B significantly reduced the number of infectious episodes in patients with RRTI. This finding suggests a first line use of this drug for the prophylaxis of infectious episodes in these patients.

Infections increase risk of arterial and venous thromboses in Danish patients with systemic lupus erythematosus: 5102 patient-years of followup.

Infections and thromboses are known complications of systemic lupus erythematosus (SLE). We investigated if infectious episodes in patients with SLE were followed by an increased risk of thrombotic events. A cohort of 571 patients with prevalent or incident SLE was followed for a mean of 8.9 ± 7.6 years. All episodes of hospitalized infections or episodes of cutaneous herpes zoster as well as arterial and venous thrombotic events were identified by retrospective chart review and prospective updating of a clinical database. For time-dependent analyses adjusted for age, sex, and ever-presence of antiphospholipid antibodies, thrombotic events were classified as occurring during the time at risk of 1 year after an infection or during the remaining control observation time. Of 271 infections identified, 104 were respiratory, 41 cutaneous herpes zoster, and 126 others. Of 159 thromboses identified, 98 were arterial. Incidence for arterial and venous thromboses within 1 year after infection was 2.18% and 2.56%, respectively, compared to patients who never had an infection (0.58 and 0.67). The adjusted 1-year risk of arterial and venous thrombosis after any infection was increased [relative rate (RR) 2.5, 95% CI 1.4-4.6, and RR 2.8, 95% CI 1.3-5.9, respectively]. Venous thromboses were in particular more prevalent after respiratory infections (RR 5.4, 95% CI 2.3-13). The temporal associations observed in this study indicate that infections could be risk factors for arterial or venous thromboses in patients with SLE, although causality was not addressed by this study.

Clinical efficacy and tolerability of an immune-stimulant(*) constituted by inactivated bacterial bodies in the prophylaxis of infectious episodes of airways: a double blind, placebo-controlled, randomized, multicentre study.

Background(Buccalin ®) is a Bacterial Lysates (BL) that belongs to a family of immune-stimulators, developed more than 30 years ago and it still has a role in the prophylaxis of Recurrent Respiratory Tract Infections (RRTI). However, original studies were conducted with an approach that does not seem to be aligned with the present methodologies. In addition, concomitant therapies substantially improved in the last decades. These two reasons strongly suggested to update our knowledge on the capacity of this bacterial lysate (Buccalin ®) to reduce the number of days with infectious episodes in patients with RRTI.MethodsA double blind, placebo-controlled, randomized, multicentre study was programmed (EudraCT code: 2011-005187-25). The reduction of the number of days with infectious episodes (IE) was the primary endpoint. Secondary endpoints were the number of IE, the use of concomitant drugs, the efficacy on signs and symptoms of RRTI and the safety of the drug. Patients were treated according to the registered schedule and were followed up for a period of 6 months.ResultsFrom a cohort of 188 patients eligible for the study, 90 were included in the active group and 88 in the placebo group. The study was completed in 170 patients. A significant reduction of the number of days with IE was observed (6.57 days in the active group and 7.47 in the placebo group). Secondary endpoints were only partially achieved. No virtual adverse events related to the treatment were recorded.ConclusionThe administration of bacterial lysate (Buccalin ®) in patients with RRTI had the capacity to significantly reduce the number of days with IE in a multicentre, randomized, placebo controlled, clinical study. The treatment was safe. Of note, all patients were free to be treated with the best concomitant therapies. In these conditions, the positive results observed demonstrated that this bacterial lysate has maintained its capacity of reducing the days with infections in patients with RRTI, also in association to the concomitant therapies available nowadays.

Patterns of Infection in Patients With Myelodysplastic Syndromes and Acute Myeloid Leukemia Receiving Azacitidine as Salvage Therapy. Implications for Primary Antifungal Prophylaxis

Incidence, etiology, and outcome of infectious episodes in patients with myeloid neoplasms receiving azacitidine are uncertain, with no prospective data available in this group of patients. The aim of the current study was to analyze the incidence and factors related to the probability of infection in a cohort of patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) treated with azacitidine who did not receive any type of antimicrobial prophylaxis. Significantly, the group of patients who received prior intensive chemotherapy had more infectious episodes (P = 10(-4)), and particularly, invasive aspergillosis (P = .015), than patients who received frontline azacitidine. Primary antifungal prophylaxis might be recommended in MDS and AML patients receiving azacitidine as salvage therapy after intensive regimens.

Effect of blood transfusion on outcome after major burn injury: A multicenter study*

To delineate blood transfusion practices and outcomes in patients with major burn injury. Patients with major burn injury frequently require multiple blood transfusions; however, the effect of blood transfusion after major burn injury has had limited study. Multicenter retrospective cohort analysis. Regional burn centers throughout the United States and Canada. Patients admitted to a participating burn center from January 1 through December 31, 2002, with acute burn injuries of >or=20% total body surface area. Outcome measurements included mortality, number of infections, length of stay, units of blood transfused in and out of the operating room, number of operations, and anticoagulant use. A total of 21 burn centers contributed data on 666 patients; 79% of patients survived and received a mean of 14 units of packed red blood cells during their hospitalization. Mortality was related to patient age, total body surface area burn, inhalation injury, number of units of blood transfused outside the operating room, and total number of transfusions. The number of infections per patient increased with each unit of blood transfused (odds ratio, 1.13; p<.001). Patients on anticoagulation during hospitalization received more blood than patients not on anticoagulation (16.3+/-1.5 vs. 12.3+/-1.5, p<.001). The number of transfusions received was associated with mortality and infectious episodes in patients with major burns even after factoring for indices of burn severity. The utilization of blood products in the treatment of major burn injury should be reserved for patients with a demonstrated physiologic need.

Selective induction of pentraxin 3, a soluble innate immune pattern recognition receptor, in infectious episodes in patients with haematological malignancy

Pentraxins are a superfamily of conserved proteins induced in response to microbial and inflammatory stimuli. Members of this family include C-reactive protein (CRP) and serum amyloid P component, collectively known as the classical short pentraxins, and the more recently discovered pentraxin 3 (PTX3), a member of the closely related subfamily of the long pentraxins. PTX3 has been shown to be produced in response to microbial infections, and highly elevated levels were reported in patients with sepsis. In this study, PTX3 levels were evaluated in sera of a group of patients with haematological malignancy. Our findings indicate that serum PTX3 was elevated in only 1/11 afebrile episodes, despite evidence of mucositis (median 1.39), in 10/10 episodes of blood stream or target organ infections (median 7.2) but, surprisingly, was normal in 5/5 episodes of invasive aspergillosis (median 1.39). The data suggest that serum PTX3 levels are elevated selectively in response to infection. These disparate responses require further study.

Infectious complications following T-cell depleted hematopoietic stem-cell transplantation

Although sepsis is a common complication during stem-cell transplantation, the prevalence of infections after hematopoietic recovery is less well known. We undertook a retrospective analysis of infectious episodes in patients who underwent allogeneic BM (n = 77) or PBSC (n = 29) grafting from HLA identical siblings. T-cell depletion of the stem-cell grafts with anti CD 52 (CAMPATH-1) Abs was employed for the prevention of GvHD. Patients' median age was 30 (4-54) years. Antibiotic prophylaxis was with oral amphotericin, ofloxacin and i.v. or oral acyclovir. Fever was treated empirically with a third generation cephalosporin and aminoglucosides until results of microbiological cultures became available. Six patients died of graft failure. GvHD was observed in 18% but in no case was it > Grade II. Only seven patients did not develop pyrexia during the initial admission or within 60 days following graft infusion. Median duration of pyrexia was 10 (range 2-49) days. A microbial source was detected in 42% and it was Gram (+) in 86%, Gram (-) in 11% and fungal in 3%. In 16 patients, indwelling venous catheters were removed due to severe infection. Subsequent to the recovery of the blood parameters, the most prevalent infection was by herpes varicella/zoster in 20; another 17 developed herpes simplex. In total 40/102 were re-hospitalized for pyrexia, which in four cases was of unknown origin. Bacterial infections with Staphylococcus Aureus and S. Epidermitis were seen in 10 and seven patients respectively. CMV was detected in seven patients. Thirteen patients died of sepsis and in 10, it was related to GvHD or graft failure. Another 20 died following recurrence of the malignancy. Overall, 39 patients died and 63% survived at a median DFS of 1992 (range 623-5092) days. We conclude that during the initial neutropenic period the dominant infections are by Gram (+) organisms, often associated with indwelling catheters. Once the BM has recovered, the main morbidity is by viral infections, but Gram+ organisms still remain common bacterial pathogens.

Increased morbidity associated with oral infection in patients with acute nonlymphocytic leukemia

The proper dental management of patients with leukemia is complicated by the compromised host defenses against infection. This compromised state is a result of the chemotherapeutic agents used in cancer treatment as well as the natural existing disease state. Infection remains the leading immediate cause of death in persons with leukemia. Previous reports have described oral complications secondary to this neoplasm and its medical management; however, relatively few studies of the incidence of systemic complications secondary to oral disease have been reported. This study analyzed the incidence of acute infectious episodes in patients with acute nonlymphocytic leukemia (ANLL). Thirty-eight patients were randomly selected for review; of these patients, twelve (32 percent) had identifiable acute oral infection associated with the presence of a febrile state (> 101° F). Seven of the twelve (58 percent) had no other identifiable sources of infection. The periodontium was the oral site most frequently involved, followed by mucosal and periapical loci. Most acute oral infections were associated with profound granulocytopenia (< 100/μl). The data suggest that oral disease plays a clinically important role in the development of systemic complications in ANLL patients.