Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00791505
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00791505
Study Brief:
Protocol Section:
NCT00791505