ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190437

Purpose

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 )

Condition	Intervention	Phase
Chronic Obstructive Lung Disease (COLD)	Drug: Amoxicillin-clavulanic	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

A 20% reduction of the duration of clinical symptoms of exacerbation is expected [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
A 20% reduction of the duration of clinical symptoms of exacerbation is expected

Secondary Outcome Measures:

The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria

Enrollment:	520
Study Start Date:	August 2003
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Amoxicillin-clavulanic	Drug: Amoxicillin-clavulanic Amoxicillin-clavulanic Other Name: Amoxicillin-clavulanic

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190437

Locations

France
Assistance Publique-Hopitaux de Paris
Paris, Ile de France, France, 75000
Hopital Henri Mondor
Creteil, Val de Marne, France, 94000

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Christian BRUN-BUISSON, Pr,MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Aurémie GUIMFACK, Department Clinical Research of developpement
ClinicalTrials.gov Identifier:	NCT00190437 History of Changes
Other Study ID Numbers:	P010310
Study First Received:	September 15, 2005
Last Updated:	April 29, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Chronic Obstructive Lung Disease (COLD)
Randomized Clinical Trial
Antibiotics
Acute Exacerbation
Mechanical

Ventilation
Intensive Care
Length of Stay
Mortality

Additional relevant MeSH terms:

Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Amoxicillin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012