Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients
- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation
- To determine the safety and tolerability of SAR279356
- To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356
- Exploratory efficacy of SAR279356 on prevention of bacterial infections
Total study duration (from screening to last follow-up visit) is 91 days break down as follows:
- Screening: 1 day prior to dosing;
- Treatment period: one IV injection on Day 1;
- Follow-up period: 90 days
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Investigational Site Number 840024
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01389700
- Information obtained from ClinicalTrials.gov on February 07, 2013
Medical and Biotech [MESH] Definitions
A broad-spectrum antibiotic that is being used as prophylaxis against disseminated Mycobacterium avium complex infection in HIV-positive patients.
The prevention of infection or disease following exposure to a pathogen. This is most frequently addressed by administering a vaccine or anti-viral medication following exposure to a virus.
The type (and only) species of RUBIVIRUS causing acute infection in humans, primarily children and young adults. Humans are the only natural host. A live, attenuated vaccine is available for prophylaxis.
An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium avium complex infection in HIV infected individuals who are at risk to develop this untreatable...
Knee prosthesis infection is a severe complication. The use of a tourniquet during surgery impairs the efficacy of the antibiotic prophylaxis. We hypothesize that the antibiotic administra...
Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of infection and the risk of appearance of kidney scars in children with a documented previous upp...
Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced abortion, and at the same time alters women's sexual behavior and prevents further re-infection by s...
Does Post-Operative Prophylaxis With Macrobid Reduce the Incidence of Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence
This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decr...
The fixed-dose combination of emtricitabine (FTC) 200 mg and tenofovir disoproxil fumarate (TDF) 300 mg (Truvada(®)), administered orally once daily, is widely used as part of first-line regimens f...
OBJECTIVE: To establish the efficacy of antibiotic prophylaxis prior to cystoscopy in outpatients in decreasing the incidence of post-procedure urinary tract infection. STUDY DESIGN AND SETTING: A ran...
Pneumocystis jirovecii dihydropteroate synthase (DHPS) gene mutations are well-reported. Although sulfa prophylaxis generally is associated with DHPS mutant infection, whether mutant infection is asso...
Antifungal prophylaxis is recommended in high-risk patients, but risk criteria remain unclear and the predictive value of Model of End-Stage Liver Disease (MELD) score is unknown. In a retrospective,...
An estimated 56,000 human immunodeficiency virus (HIV) infections occur each year in the United States. Men who have sex with men (MSM) account for 53% of the estimated incident infections, and survei...