Status:
COMPLETED
ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Chronic Obstructive Lung Disease (COLD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 s...
Detailed Description
This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo.
Eligibility Criteria
Inclusion
- 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
- Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00190437
Start Date
August 1 2003
End Date
October 1 2006
Last Update
May 2 2011
Active Locations (2)
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1
Hopital Henri Mondor
Créteil, Val de Marne, France, 94000
2
Assistance Publique-Hopitaux de Paris
Paris, Île-de-France Region, France, 75000