NCT01559753

Early-onset Ventilator-associated Pneumonia in Adults: Comparison of 8 Versus 15 Days of Antibiotic Treatment

Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pneumonia Ventilator Associated

Interventions

Type	Name	Description
DRUG	Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin	All patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group. * Beta-Lactams: * Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS * Ceftriaxone : 2 g OD during 3 days, then 1 g OD * Cefotaxime : 2 g TDS during 3 days, then 1 g TDS * Aminoglycosides * Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure) * Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure) * Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)
DRUG	compare 8 to15 days of antibiotic treatment	All patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group. • Beta-Lactams: * Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS * Ceftriaxone : 2 g OD during 3 days, then 1 g OD * Cefotaxime : 2 g TDS during 3 days, then 1 g TDS Aminoglycosides * Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure) * Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure) * Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)

Timeline

• Start date: 1998-01-01
• Primary completion: 2002-09-01
• Completion: 2002-11-01
• First posted: 2012-03-21
• Last updated: 2012-03-21