Pneumonia Ventilator Associated Clinical Trial
Official title:
Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia
The duration of treatment of community acquired pulmonary infection varies between 5 and 14 days according to the authors (22), or even 3 days with new drugs having long half-life (2). For nosocomial pulmonary infection, treatment durations are not standardized (5). It is simply mentioned the concept of "usual" treatment of at least 15 days. However, recent studies used 10 days of treatment without significant decrease in the rate of healing compared to usual treatment. It is essential to clarify the optimal duration of antibiotic treatment. Indeed, any excessive extension of treatment may increase the occurrence of adverse effects (renal toxicities, hepatic...), and induce resistance of bacteria to antibiotics (selection pressure), colonization of the patient by Multiresistant bacteria and an increase in the cost of treatment
This is a prospective, randomized, open, multi-center study.
3.1 Primary Objective
Show that antibiotic therapy of 8 or 15 days is equivalent in terms of clinical cure rates
in the treatment of early onset nosocomial pulmonary infection in patients under mechanical
ventilation.
3.2 Secondary Objective
- Study of nosocomial infections: assessing the influence of the duration of antibiotic
treatment on the rate of fatal pulmonary and extra-pulmonary infection (definition of
nosocomial infections: annex XIII).
• Study of bacterial Ecology: research of changes in the flora of the gut under
treatment and analysis of pathological samples (antibiotic resistance phenotypes
+/-genotypes).
- Economic Survey: analyze the costs related to the treatment of nosocomial pneumonia and
its complications in two study groups.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment