Status:
COMPLETED
Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation
Lead Sponsor:
University of Monastir
Conditions:
Chronic Obstructive Pulmonary Disease
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiot...
Detailed Description
Antibiotic therapy has been shown to be beneficial in patients with severe acute exacerbation of chronic obstructive pulmonary disease (COPD). Although recent guidelines support the use of new antibio...
Eligibility Criteria
Inclusion
- All patients having a COPD (according to the definition of the American Thoracic Society) and having an acute exacerbation leading to an acute respiratory failure requiring the admission to ICU and mechanical ventilation.
- The acute exacerbation of COPD is defined by increase in the frequency of cough, the volume and the purulence of expectoration and increase of baseline dyspnea. To be included, patients must have respiratory rate \>30 cycles/min and one of the following blood gas criteria (with blood gases performed right before the initiation of mechanical ventilation): PaC02 \> 6kPa and arterial pH \<7.30.
Exclusion
- Pneumonia documented with chest radiography
- Antibiotic treatment in the ten previous days of ICU admission
- Former inclusion in the study
- History of allergy to the quinolones and/or to trimethoprim sulfamethoxazole
- Pregnancy or breast feeding
- Severe chronic disease: heart, liver, kidney.
- Known immunodeficiency (malignant hemopathy, AIDS...)
- Digestive disease which could affect the absorption of the drugs
- Concomitant infection which requires systemic antibiotic treatment
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00791505
Start Date
July 1 2002
End Date
June 1 2005
Last Update
February 24 2020
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