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Infection clinical trials

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NCT ID: NCT02452047 Completed - Clinical trials for Bacterial Infections

Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013)

RESTORE-IMI 1
Start date: August 21, 2015
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A) versus colistimethate sodium+imipenem+cilastatin in the treatment of imipenem-resistant bacterial infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI).

NCT ID: NCT02451163 Completed - Common Cold Clinical Trials

DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly

Fib-CC-2014
Start date: September 2014
Phase: Phase 2
Study type: Interventional

The aim of the study is to measure the effect of wheat polysaccharides on the occurence of common cold (CC) in elderly during a 12-week consumption period.

NCT ID: NCT02447172 Completed - Infection Clinical Trials

Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

COACT-2
Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.

NCT ID: NCT02445859 Completed - Clinical trials for Surgical Site Infection

Continuous Antibiotic Prophylaxis in Colorectal Surgery

Colo-Pro
Start date: August 2015
Phase: Phase 2
Study type: Interventional

We propose to randomise patients due to undergo colorectal surgery to standard antibiotic prophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical wound infection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime, repeated every 4 hours. The intervention regimen is a loading dose of cefuroxime followed by a continuous infusion of cefuroxime until the end of surgery. The intervention regimen dosing will be calculated using a patient's renal function and body weight. The intervention regimen will target a free serum drug concentration of 64mg/L. This serum level is 4x the MIC90 for colonising Enterobacteriaceae. The rational for this dosing regimen is summarised below. The primary objective of the study is to reduce by 50% the rate of surgical wound infections after colorectal surgery.

NCT ID: NCT02444975 Completed - Clinical trials for Recurrent Urinary Tract Infection

The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST

S-HYDRACYST
Start date: December 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether increased water intake is effective in preventing episodes of uncomplicated urinary tract infections (UTI) in pre-menopausal women suffering from UTI recurrences.

NCT ID: NCT02442271 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

Start date: April 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3b, open-label, multicenter study to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12), in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin.

NCT ID: NCT02439632 Completed - Clinical trials for Acute Lower Urinary Tract Infection

A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control

Start date: February 2014
Phase: Phase 3
Study type: Interventional

prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated lower urinary tract infection in chinese

NCT ID: NCT02438293 Completed - Clinical trials for Congenital Heart Disease

'The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery'

RISK
Start date: June 2015
Phase:
Study type: Observational

This is a prospective single- center observational study in the Leiden University Medical Center in approximately 250 children (<12 years) undergoing elective cardiac surgery, for congenital heart disease. The parents/guardians of the children will be asked to fill out a questionnaire, to asses respiratory symptoms in the last weeks, before the operation of their child. In the operating theatre, a nasopharyngeal swab will collected. Clinical data will be collected daily during paediatric intensive care admission, and date of discharge from paediatric intensive care unit and from hospital are recorded. If children are still intubated at day 4 a second nasopharyngeal swab and residual blood will be collected. The samples will be tested for rhinovirus with a polymerase chain reaction. Main study parameter is the paediatric intensive care unit length of stay in per-operative rhinovirus -positive compared to rhinovirus-negative patients.

NCT ID: NCT02437591 Completed - Clinical trials for Inflammatory Bowel Disease (IBD)

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

PROFILE
Start date: August 13, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI). This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

NCT ID: NCT02434510 Completed - Infection Clinical Trials

Bacterial Contamination of Operative Splash Basins

Start date: March 2015
Phase: N/A
Study type: Observational

The primary objective of this study is to compare the efficacy of adding 0.05% chlorhexidine gluconate to the splash basin in reducing bacterial growth from splash basins at the end of a total joint replacement procedure. Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at the end of elective total joint arthroplasty cases. Null Hypothesis: There will be no difference in bacterial growth from the splash basin at the end of the case despite the addition of an antimicrobial solution.