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

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT00791505

Collaborator

(none)

170

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Sepsis Antibiotics	Drug: ciprofloxacin Drug: trimethoprim-sulfamethoxazole	Phase 3

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Antibiotic Comparison Exacerbation COPD

Study Start Date :

Jul 1, 2002

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ciprofloxacin 750 mg a day during 10 days	Drug: ciprofloxacin 1500 mg a day for 10 days Other Names: fluoroquinolone
Active Comparator: trimethoprim-sulfamethoxazole 2000 mg a day for 10 days	Drug: trimethoprim-sulfamethoxazole 2000 mg a day for 10 days Other Names: sulfatrim bactrim

Arm

Intervention/Treatment

Active Comparator: Ciprofloxacin

750 mg a day during 10 days

Drug: ciprofloxacin

1500 mg a day for 10 days

Other Names:

fluoroquinolone

Active Comparator: trimethoprim-sulfamethoxazole

2000 mg a day for 10 days

Drug: trimethoprim-sulfamethoxazole

2000 mg a day for 10 days

Other Names:

sulfatrim

bactrim

Outcome Measures

Primary Outcome Measures

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. [30 day after starting protocol]
The decision to initiate new antibiotics was left to the discretion of the treating physician, and if resistant species were cultured, the protocol treatment was not systematically changed unless the clinical course of the patient worsened

Secondary Outcome Measures

Mechanical ventilation duration [30 days after starting protocol]
duration of mechanical ventilation
Duration of hospital stay [30 days after starting protocol]
duration of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.