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

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

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

Conditions
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Chronic Obstructive Lung Disease (COLD)

Intervention / Treatment
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* Drug: Amoxicillin-clavulanic


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Amoxicillin-clavulanic | Drug: Amoxicillin-clavulanic<br>* Amoxicillin-clavulanic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during de study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Lung Disease (COLD), Randomized Clinical Trial, Antibiotics, Acute Exacerbation, Mechanical, Ventilation, Intensive Care, Length of Stay, Mortality