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 )
This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
520
Amoxicillin-clavulanic
Hopital Henri Mondor
Créteil, Val de Marne, France
Assistance Publique-Hopitaux de Paris
Paris, Île-de-France Region, France
A 20% reduction of the duration of clinical symptoms of exacerbation is expected
A 20% reduction of the duration of clinical symptoms of exacerbation is expected
Time frame: during de study
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria
Time frame: during the study
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