Overview

Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation

Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
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 antibiotic has any impact on outcome. Our aim was to compare the effects of the combination of trimethoprim and sulfamethoxazole and ciprofloxacin in patients treated for severe COPD exacerbation requiring mechanical ventilation.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Monastir
Treatments:
Ciprofloxacin
Fluoroquinolones
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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