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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190437
First Posted: September 19, 2005
Last Update Posted: May 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]
    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 ]
    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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Aurémie GUIMFACK, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190437     History of Changes
Other Study ID Numbers: P010310
First Submitted: September 15, 2005
First Posted: September 19, 2005
Last Update Posted: May 2, 2011
Last Verified: March 2007

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents