Clinical trial NCT01559753: Early-onset Ventilator-associated Pneumonia in Adults: Comparison of 8 Versus 15 Days of Antibiotic Treatment
Official title: Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia Ventilator Associated
Keywords: Antibiotic
treatment
ventilator associated pneumonia
duration
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: French Society for Intensive Care
name: SmithKline Beecham
name: GlaxoSmithKline
First posted: 2012-03-21
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Cure of respiratory infection
timeFrame: 21 days after inclusion
Secondary outcomes:
measure: Rate of secondary infections
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Gilles R CAPELLIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capellier G, Mockly H, Charpentier C, Annane D, Blasco G, Desmettre T, Roch A, Faisy C, Cousson J, Limat S, Mercier M, Papazian L. Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment. PLoS One. 2012;7(8):e41290. doi: 10.1371/journal.pone.0041290. Epub 2012 Aug 31.