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NCT Number: NCT00190437

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

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 )

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Key information

Conditions

Chronic Obstructive Lung Disease (COLD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Henri Mondor, Créteil, Val de Marne, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin-clavulanic

Drug

Amoxicillin-clavulanic

Primary outcomes

  1. A 20% reduction of the duration of clinical symptoms of exacerbation is expected

    Time frame: during de study

    A 20% reduction of the duration of clinical symptoms of exacerbation is expected

Secondary outcomes

  1. The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria

    Time frame: during the study

    The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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