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NCT ID: NCT01595438 Completed - Clinical trials for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

NCT ID: NCT01594762 Completed - Clinical trials for Diabetic Foot Infection

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

OneStep-2
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

NCT ID: NCT01593592 Completed - Clinical trials for Helicobacter Pylori Infection

Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Start date: June 2012
Phase: N/A
Study type: Interventional

Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

NCT ID: NCT01590758 Completed - Clinical trials for Diabetic Foot Infection

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

OneStep-1
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

NCT ID: NCT01587131 Completed - Clinical trials for Respiratory Tract Infections

DNA-based Influenza Vaccine in the Elderly

Start date: June 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine.

NCT ID: NCT01586962 Completed - Clinical trials for Upper Respiratory Infections

Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI

Start date: May 2012
Phase: Phase 3
Study type: Interventional

This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population. The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor. The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category: 1. mild to moderate body pain, headache, fever or sore throat 2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Adolescents will be included in the study population

NCT ID: NCT01582711 Completed - Clinical trials for Latent Tuberculosis Infection

Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT

iAdhere
Start date: September 2012
Phase: Phase 3
Study type: Interventional

The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). The secondary objectives: - To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders - To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among participants who complete treatment and those who discontinue therapy prior to completion. - To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study. - To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually) - To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms - To collect patient-specific cost data related to the 3 treatment arms - To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.

NCT ID: NCT01581047 Completed - Infection Clinical Trials

Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units

AMOCEF
Start date: March 15, 2012
Phase:
Study type: Observational

Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure… The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics. In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.

NCT ID: NCT01579370 Completed - Clinical trials for Healthcare Associated Infections

Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)

Start date: April 2012
Phase: N/A
Study type: Interventional

Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

NCT ID: NCT01577862 Completed - Clinical trials for Pneumonia, Ventilator-Associated

Colistin and Rifampicin for MDR-Acinetobacter

CoRAb
Start date: November 2008
Phase: Phase 3
Study type: Interventional

Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. However, colistin is not registered for this indication. The addition of rifampicin to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been studied in comparison with colistin alone. The purpose of this randomised, open-label, multicentre clinical trial is to assess whether the association of colistin and rifampicin reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone. The trial will enroll 210 patients from intensive care units (ICU) of five tertiary care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin alone (control arm) or colistin plus rifampicin (experimental arm). Primary end point is overall mortality, defined as death occurring within 30 days from randomisation. Secondary end points will be disease-specific death, microbiological eradication, hospitalization length, emergence of resistance to colistin during treatment.