ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD

Condition(s) targeted: Chronic Obstructive Lung Disease (COLD)

Intervention: Amoxicillin-clavulanic (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Christian BRUN-BUISSON, Pr,MD,PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.

The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )

Official title: ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: A 20% reduction of the duration of clinical symptoms of exacerbation is expected

Secondary outcome: The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria

Detailed description: This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients included are those with documented or suspected COLD, exclusive of other

bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ.

Exclusion Criteria:

- Patients recently hospitalised, having received antibiotics since more than 24h, or on

long-term steroids will not be included

Assistance Publique-Hopitaux De Paris, PARIS, Ile De France 75000, France

Hopital Henri Mondor, CRETEIL, Val De Marne 94000, France

Starting date: August 2003
Ending date: October 2006
Last updated: March 13, 2007