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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: French Society for Intensive Care; GlaxoSmithKline; SmithKline Beecham
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; beta-Lactams; Cefotaxime; Cefoxitin; Ceftriaxone; Clavulanic Acid; Clavulanic Acids; Lactams; Netilmicin; Tobramycin

Criteria

Inclusion Criteria:

Early onset nosocomial pneumonia in patients under mechanical ventilation since at least 24 h Patients aged 18 years or more The patient must be able to receive either one of the two arms of treatment defined for the study Information on the patient and his family informed consent obtained during the first three days Bacteria sensitive to the specified antibiotic regimen

Exclusion Criteria:

• Patients do not match the criteria for inclusion

• 18 years of age, pregnant Patients

• Another infectious outbreak documented the day of the BAL.

• Patients with acquired immunosuppression (blood diseases, HIV,...), induced (immunosuppressive drugs, cancer, radiation therapy) or congenital.

• Steroids for a period exceeding 15 days.

• Leukopenia (1000 GB/mm (or neutropenia (500 PN/mm)

• Purulent pleural effusion, pulmonary abscess

• Cystic fibrosis

• Antibiotic treatment according to the following terms:

1. Ongoing curative antibiotic therapy

2. Antibiotics within 3 days before the diagnosis of VAP, except surgical antibiotic prophylaxis (defined according to the consensus conference "antibiotic prophylaxis in the surgical environment in adult" December 11, 1992) (27)

3. Use of antibiotics not authorized in the study (see list)

• Allergy to antibiotics used in the study

• Inclusion in another study assessing antibiotic treatment, either the treatment or prevention of nosocomial pulmonary disease

• Refusal to participate

• Lack of informed consent by the patient or his family