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Communicable Diseases clinical trials

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NCT ID: NCT03363451 Recruiting - Infection Clinical Trials

A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)

Start date: February 1, 2018
Phase:
Study type: Observational

The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.

NCT ID: NCT03362632 Enrolling by invitation - Infection Clinical Trials

A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)

Start date: July 1, 2018
Phase:
Study type: Observational

Spontaneous bacterial peritonitis (SBP) is a common complication of end-stage liver disease due to various causes. The initial anti-infective medication is appropriate and the patient's survival rate is closely related. Ascitic fluid bacterial culture takes a long time, the positive rate is low, it is difficult to guide the timely use of antimicrobial drugs, empirical medicine based on evidence-based medicine for SBP in patients with end-stage liver disease is essential. The American College of Hepatology and the European Society of Hepatology recommend the use of third-generation cephalosporins as the first choice of empirical therapy in patients with end-stage liver disease associated with community-acquired SBP. Patients with merger of hospital-acquired SBP with piperacillin / tazobactam or carbapenem +/- glycopeptide antibiotics is the first choice for empirical medication. There is no clear recommendation in China. In recent years, the conclusions of international clinical research in this area have been in disagreement with the recommendations. As a key factor in the selection of empirical antibiotics is local bacterial resistance data, these findings are difficult to evidence-based medicine for Chinese doctors. This project intends to observe the efficacy of different initial anti-infective regimens in Chinese patients with end-stage liver disease with SBP and 30-day and 60-day non-liver transplant survival rates, providing evidence-based medical evidence for the empirical use of such patients.

NCT ID: NCT03361670 Completed - Clinical trials for Lower Resp Tract Infection

Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel

LRTI
Start date: October 2016
Phase: N/A
Study type: Observational

This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively collect and test residual Bronchoalveolar lavage (BAL) and sputum specimens and generate performance data to support regulatory classification of the FilmArray LRTI as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.

NCT ID: NCT03361163 Completed - Clinical trials for Bacterial Infections

Controlled Human Infection for Vaccination Against Streptococcus Pyogenes

CHIVAS
Start date: July 10, 2018
Phase: Phase 1
Study type: Interventional

Group A Streptococcus (GAS) infection is a major cause of death and disability globally with a disproportionately high burden in settings of disadvantage worldwide. Acute infections due to GAS range from very common superficial skin infections (>150 million prevalent cases) and pharyngitis (over 600 million incident cases) to life-threatening invasive disease (>600,000 incident cases) such as necrotising fasciitis. Post-infectious GAS sequelae of GAS include acute rheumatic fever (ARF, ~500,000 incident cases) leading to rheumatic heart disease (RHD, ~34 million prevalent cases), and acute glomerulonephritis. The health services impact of GAS disease in all its forms is immense and strikes at every level from primary to intensive care. Controlled human infection models (CHIMs) have a long history of critical contributions to vaccine development. Data from CHIMs meeting modern scientific, regulatory, and ethical standards, are aiding efforts to control over 25 major human pathogens, including bacteria (e.g. pneumococcus, cholera), viruses (e.g. respiratory syncytial virus, influenza), and parasites (e.g. malaria, schistosomiasis). A reliable and safe controlled human infection model of GAS pharyngitis will be an important part of the global vaccine development effort. To build the model, the investigators are undertaking a dose-ranging study using an observational, dose-escalation, inpatient trial to determine the dose of GAS administered by direct oropharyngeal inoculation (bacteria 'painted' onto throat) required to reliably produce a pharyngitis attack rate of ≥ 60% in carefully screened healthy adult volunteers.

NCT ID: NCT03361085 Terminated - Clinical trials for Hospital-acquired Pneumonia

Modular Prevention Bundle for Non-ventilator-associated Hospital-acquired Pneumonia (nvHAP)

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Background: Hospital acquired pneumonia (HAP) is divided in two distinct groups, ventilator-associated pneumonia (VAP) and non-ventilator-associated HAP (nvHAP). Although nvHAP occurs more frequently than VAP and results in similar mortality and costs, prevention guidelines and prevention focus almost exclusively on VAP. Scientific evidence about nvHAP prevention is scarce. Therefore, we designed a mixed-methods study to investigate the effectiveness of a newly developed nvHAP prevention bundle and factors that influence its implementation. Methods: This single-centre project at the 950-bed University Hospital Zurich (UHZ) will engage the wards of nine departments with substantial nvHAP rates. The nvHAP bundle consists of five primary prevention measures: 1) oral care, 2) identification and treatment of patients with dysphagia, 3) mobilization, 4) stopping unnecessary proton pump inhibitors, and, 5) respiratory therapy. Implementation includes the engagement of department-level implementation teams, who sustain the 'core' intervention components of education, training, and environmental restructuring and adapt the implementation strategy to local needs. The effects of the implementation will be analysed by a mixed-method approach. As primary outcome, nvHAP incidence rates will be analysed by Poisson regression models to compare incidence rates before, during, and after the implementation phases (on the hospital and department level). In addition, the association between process indicators and nvHAP incidence rates will be analysed using longitudinal Poisson regression models. A longitudinal, qualitative study and formative evaluation based on interviews and focus groups identifies supporting or hindering factors for implementation success in participating departments dynamically over time. This accumulating implementation experience will be constantly fed back to the implementation teams and thus, represents an active implementation element. Discussion: This comprehensive mixed-methods study is designed to accomplish both, measure the effectiveness of a new prevention bundle against nvHAP and provide insights into how and why it worked or failed. The results of this study may contribute substantially to patient safety in the area of a rediscovered healthcare-associated infection - nvHAP.

NCT ID: NCT03360877 Completed - Clinical trials for Severe Acute Malnutrition

Prevention of Nosocomial Infections (CleanKids)

CleanKids
Start date: September 5, 2016
Phase: N/A
Study type: Interventional

While the standardization of treatment protocols for Severe Acute Malnutrition (SAM) has helped to reduce historically high mortality, mortality in inpatient settings remains substantial, likely due to the severity of complications associated with late presentation and health-care associated infection (HCAI). The purpose of this study is to serve as an important stand-alone description to inform the understanding of the magnitude of the problem and help guide implementation of measures to reduce the risk of nosocomial infection and multi-drug resistance.

NCT ID: NCT03354754 Terminated - Clinical trials for Intra-abdominal Infections

LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)

Start date: May 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections. It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed. PK analysis was not conducted as per protocol the first analysis required 8 patients.

NCT ID: NCT03354598 Completed - Clinical trials for Uncomplicated Urinary Tract Infections

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

NCT ID: NCT03353532 Completed - Clinical trials for Staphylococcus Aureus

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

SALT
Start date: August 1, 2017
Phase:
Study type: Observational

This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias. Data will be assessed in two populations. Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery. Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI. If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded. The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured. Matching criteria comprise the following: - Type of procedure - Age - ASA score - BMI - Duration of procedure (as percentile for this procedure) - Diabetes - Sex

NCT ID: NCT03353506 Completed - Clinical trials for Recurrent Clostridium Difficile Infection

Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

Start date: February 14, 2018
Phase: Phase 2
Study type: Interventional

Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry. Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).