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ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
This study is ongoing, but not recruiting participants.
Study NCT00190437   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: September 15, 2005   Last Updated: March 13, 2007   History of Changes

September 15, 2005
March 13, 2007
August 2003
 
A 20% reduction of the duration of clinical symptoms of exacerbation is expected
Same as current
Complete list of historical versions of study NCT00190437 on ClinicalTrials.gov Archive Site
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria
Same as current
 
ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
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 )

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

Phase IV
Interventional
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment
Chronic Obstructive Lung Disease (COLD)
Drug: Amoxicillin-clavulanic
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
520
October 2006
 

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190437
 
P010310, AOM01075, ANTEAB
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Christian BRUN-BUISSON, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP