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

NCT00190437 | Completed Phase 4 DMC

• 1 other identifier: P010310
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

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 )

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  during the study

Study Arms (1)

1

EXPERIMENTAL

Amoxicillin-clavulanic

Drug: Amoxicillin-clavulanic

Interventions

Amoxicillin-clavulanic DRUG

Amoxicillin-clavulanic

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hopital Henri Mondor

Créteil, Val de Marne, 94000, France

Location

Assistance Publique-Hopitaux de Paris

Paris, Île-de-France Region, 75000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Christian BRUN-BUISSON, Pr,MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 2, 2011

Record last verified: 2007-03

Locations

FR (2)