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

NCT01559753 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2012-03-21

No results posted yet for this study

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

Conditions

  • Pneumonia Ventilator Associated

Interventions

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)

Sponsors & Collaborators

  • French Society for Intensive Care

    collaborator OTHER

  • SmithKline Beecham

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Gilles R CAPELLIER, MD, PhD · Centre Hospitalier Universitaire de Besancon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Primary Completion
2002-09-30
Completion
2002-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01559753 on ClinicalTrials.gov