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


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.
Fartoukh
M
M
Service de Pneumologie et Réanimation Respiratoire, Hôpital Tenon, Paris, France.
Similowski
T
T
Brun-Buisson
C
C
D000208:Acute Disease; D000284:Administration, Oral; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D003422:Critical Care / Q000379:methods*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D017052:Hospital Mortality; D006801:Humans; D015994:Incidence; D007442:Intubation, Intratracheal / Q000009:adverse effects; D007902:Length of Stay / Q000706:statistics & numerical data; D009017:Morbidity; D015337:Multicenter Studies as Topic / Q000379:methods; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012141:Respiratory Tract Infections / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination