Trimethoprim-Sulfamethoxazole Versus Ciprofloxacin in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation
Information source: University of Monastir
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease; Sepsis; Antibiotics
Intervention: ciprofloxacin (Drug); trimethoprim-sulfamethoxazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Monastir Official(s) and/or principal investigator(s): nouira semir, MD, Principal Investigator, Affiliation: research unit 04/UR/08-20
Summary
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 antibiotics there is no evidence that newer antibiotics are any
better than older agents. The choice of antibiotic to be used in this situation is
challenging to the clinician who must choose between traditional antibiotics (cyclins,
aminopénicillins, cotrimoxazole...) and new antimicrobial agents. Indeed, available
comparative studies did not show an obvious superiority of new antibiotics compared to their
predecessors . Taking into account bacterial agents associated to COPD exacerbations, one
must choose an antibiotic which has the best activity against Haemophilus influenzae,
Streptococcus pneumoniae and Branhamella catarrhalis. News quinolones are represented as an
interesting alternative to standard antibiotics because of their large spectrum of action
and of their pharmacokinetic advantages allowing high tissue penetration in the pulmonary
parenchyma and tracheobronchial tree. Data on their use among patients having moderate
exacerbation of COPD are encouraging but their effectiveness in more severe presentations is
not established. The objective of this randomized controlled and double blind study is to
evaluate the effectiveness and tolerance of ciprofloxacin compared to trimethoprim
sulfamethoxazole in patients admitted to ICU for severe exacerbation of COPD requiring
mechanical ventilation.
Clinical Details
Official title: Antibiotic Comparison Exacerbation COPD
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Two major criteria will be used for the determination of sample size and the estimate of the effectiveness of the treatments of the study: 1. mortality (in ICU and in the hospital) 2. rate of additional antibiotherapy course.
Secondary outcome: Mechanical ventilation durationDuration of hospital stay
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: July 2002
Last updated: November 13, 2008
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