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

Primary Purpose

Chronic Obstructive Lung Disease (COLD)

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Amoxicillin-clavulanic
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Lung Disease (COLD) focused on measuring Chronic Obstructive Lung Disease (COLD), Randomized Clinical Trial, Antibiotics, Acute Exacerbation, Mechanical, Ventilation, Intensive Care, Length of Stay, Mortality

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique-Hopitaux de Paris
  • Hopital Henri Mondor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Amoxicillin-clavulanic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2005
Last Updated
April 29, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00190437
Brief Title
ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
Official Title
ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease (COLD)
Keywords
Chronic Obstructive Lung Disease (COLD), Randomized Clinical Trial, Antibiotics, Acute Exacerbation, Mechanical, Ventilation, Intensive Care, Length of Stay, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Amoxicillin-clavulanic
Intervention Type
Drug
Intervention Name(s)
Amoxicillin-clavulanic
Intervention Description
Amoxicillin-clavulanic
Primary Outcome Measure Information:
Title
A 20% reduction of the duration of clinical symptoms of exacerbation is expected
Description
A 20% reduction of the duration of clinical symptoms of exacerbation is expected
Time Frame
during de study
Secondary Outcome Measure Information:
Title
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria
Description
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria
Time Frame
during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian BRUN-BUISSON, Pr,MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hopitaux de Paris
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75000
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
State/Province
Val de Marne
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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