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

Phase 4

Completed

• Conditions: Chronic Obstructive Lung Disease (COLD)
• Interventions: Drug: Amoxicillin-clavulanic

• Registration Number: NCT00190437
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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 )

Detailed Description

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

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-19
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2007-03
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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.

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Exclusion Criteria

• Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Amoxicillin-clavulanic	Amoxicillin-clavulanic

Primary Outcome Measures

Name	Time	Method
A 20% reduction of the duration of clinical symptoms of exacerbation is expected	during de study	A 20% reduction of the duration of clinical symptoms of exacerbation is expected

Secondary Outcome Measures

Name	Time	Method
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria	during the study	The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria

Trial Locations

Locations (2)

Assistance Publique-Hopitaux de Paris; 🇫🇷 Paris, Ile de France, France

Hopital Henri Mondor; 🇫🇷 Creteil, Val de Marne, France