[ANTEAB: a study of early antibiotic therapy in intensive care management of acute exacerbations of chronic obstructive lung disease]

Abstract

Introduction: 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 and/or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The potential benefit of routine antibiotic therapy in the absence of evidence 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.

Methods: This is a multicenter, randomized, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo. 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 failure. Patients recently hospitalized, having received antibiotics for > 24 h, or on long-term steroids will not be included. Co-interventions (bronchodilators, steroids) are controlled for. Patients will be administered the antibiotic or placebo within 24 hours of admission.

Expected results: A 20% reduction of the duration of clinical symptoms of exacerbation is expected. To this end, 520 patients are planned to be included in 15 centers in a 2-year period. Secondary end-points are the incidence of documented infection (lower respiratory tract or other sites), antibiotic use, the proportion of patients having infection with resistant bacteria, the incidence of endotracheal intubation, the duration of stay and mortality in the ICU and the hospital.