View clinical trials related to Infections.
Filter by:The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it. This study will be conducted in 3 parts: In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B. The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo. To participate in this study participants must meet the following criteria: 1. Age 1 month to 36 months 2. Weight ≥ 3.5 kg 3. Diagnosis of LRTI 4. Diagnosis of RSV 5. Hospitalization due to RSV LRTI
BK virus-associated nephropathy (BKVAN), a consequence of the strong immunosuppressive therapy given after kidney transplantation (KT), represents a growing medical problem in the KT setting. BKV replication occurs in 30-50% of recipients with progression to BKVAN in up to 10% of patients which ultimately leads to graft dysfunction and loss. Furthermore, early BKV replication after transplantation increases the risk of late acute rejection. At present, there are no BKV-specific antiviral therapies available. The current management of BKVAN relies on preemptive adaptation of immunosuppression according to viral load monitoring. However, due to its delayed nature, this empirical strategy is not always successful, and can increase the risk of donor specific antibodies, graft rejection and death. In a prospective longitudinal study, the investigators have demonstrated that the amount and kinetics of BKV genotype-specific neutralizing antibody (NAb) titers influence BKV disease severity after KT; and defined a cutoff NAb titer value of 4 log10 that allows stratification of recipients into lower and higher BKV disease risk groups prior to KT. Furthermore, our data on donor/recipient pairs provide support for the view reported by recent studies that early BKV replication in kidney transplant recipients is of donor origin. These data support the potential benefit of administering NAbs as a preventive strategy against BKV infection. The investigators and others have demonstrated the presence of high titers of BKV NAbs in commercial intravenous immunoglobulins (IVIG). The investigators further evaluated the titer of BKV NAbs in plasma samples of transplant recipients after administration of IVIG. The investigators demonstrated that all patients show an increase of NAb titers in plasma after IVIG administration. The aim of the investigators study is to investigate the efficacy of IVIG for prevention of BKV viremia after KT according to pre-transplant BKV genotype-specific NAb titers against the donor's BKV strain. The study is a multicentric prospective randomized open trial evaluating the impact of administration of IVIG for prevention of BKV viremia compared to no specific treatment in kidney transplant recipients harboring neutralizing antibody titers (NAbs) ≤ 4log10 against the BKV donor's genotype. Recipients harboring BKV NAb titer ≤ 4log10 against the BKV genotype of their matched donor and negative or non-detectable BKV load in blood at day of transplantation will be randomized to receive (experimental group) or not (control group) IVIG treatment. In the experimental group, patients will receive a single dose of IVIG at day 10+/- 4 days, day 41 +/- 7 days and day 62 +/- 7 days. The dose of IVIG is defined according the donor BKV genotype: genotype I: 0.4 g/Kg/day; genotype II and IV: 1g/kg/day. The incidence of BKV viremia (> 4 log10 copies/mL) 6 months after transplantation will be evaluated and compared between the two groups.
A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.
The purpose of this study is to evaluate the clinical value of high throughput sequencing of infectious pathogens for patients with severe infection, and to establish foundation for high throughput sequencing to be the clinical routine infection pathogen examination. This study is a diagnostic study, and the sample size is 320 cases. 320 participants from the department of hematology and intensive care unit who meet the inclusion criteria are randomly divided into the control group and the experimental group with 160 cases in each group. Both the participants of the control group and the experimental group undergo routine clinical diagnosis methods and treatment. In addition, the participants of the experimental group are collected the samples including whole blood, cerebrospinal fluid or alveolar lavage fluid required for high throughput sequencing of infectious pathogens during sample collection for routine pathogenic examination of infection. The pathogen diagnosis rate and the diagnostic accuracy rate between the conventional infectious pathogen tests and the high throughput sequencing of infectious pathogens will be compared in the experimental group. By gathering statistics of consultation hours and cost efficiency, the effect of high throughput sequencing of infectious pathogens on the diagnosis and treatment efficiency of the experimental group and the control group will be compared, and through these indicators, clinical application value for the diagnosis of severe infection patients by high throughput sequencing of infectious pathogens can be evaluated.
Antimicrobial resistance rates have reached alarming levels and the Worlds Health Organisation (WHO) states it constitutes a serious public health concern by threatening one of the most effective and mortality lowering interventions in modern medicine. Part of the solution to this problem includes minimizing overuse of antibiotics. But clinical signs alone are often not reliable to guide antibiotic treatment decisions and additional tests may be warranted to assist the doctor. Such tests include point-of-care biomarkers of infection like C-reactive protein (CRP) and procalcitonin (PCT). Targeting antibiotic use to the few patients with a high probability of benefit and withholding in the many with non-serious respiratory infection is a promising strategy and readily implemented in clinical practice. The Procalcitonin guided Antibiotics in Respiratory Infections (PARI) study will assess the effect of a novel point-of-care PCT guided antibiotic stewardship in acute respiratory tract infections in general practice. The overall aim of the PARI study is to reduce antibiotic use in patients with acute respiratory tract infections by targeting antibiotic treatment only to patients with a suspected bacterial etiology and thus likely to benefit from antibiotic therapy. The main research questions are: Does the addition of a point-of-care Procalcitonin test to standard care reduce antibiotic use in primary care? Is the intervention safe for the patients? The PARI study is a pragmatic two-arm (intervention and control (standard care) open randomized non-inferiority trial (up to 1 day difference in recovery) in general practice.
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
Hemodialysis patients are at high-risk for infections, specifically Staphylococcus aureus infections. The investigators propose to 1) implement a novel intervention (nasal povidone-iodine at each hemodialysis session) to prevent S. aureus infections using a stepped-wedge cluster randomized trial, and 2) evaluate the feasibility and acceptability of this intervention. If successful, this intervention can be used among hemodialysis patients, and evaluated in other high-risk patient populations to prevent S. aureus infections.
The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue. In addition, evaluating whether this intervention, ie SNAPS, helps patients get on PrEP and stay on PrEP to prevent STIs like HIV. PrEP is a medication that needs to be taken on a regular basis in order to be effective to prevent HIV transmission.
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.