Trimethoprim-Sulfamethoxazole Versus Ciprofloxacin in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation

This study has been completed.
Sponsor:
Information provided by:
University of Monastir
ClinicalTrials.gov Identifier:
NCT00791505
First received: November 12, 2008
Last updated: November 13, 2008
Last verified: November 2008
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic Comparison Exacerbation COPD

Resource links provided by NLM:


Further study details as provided by University of Monastir:

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. [ Time Frame: 30 day after starting protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mechanical ventilation duration [ Time Frame: 30 days after starting protocol ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: 30 days after starting protocol ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: July 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ciprofloxacin
750 mg a day during 10 days
Drug: ciprofloxacin
1500 mg a day for 10 days
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791505

Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: nouira semir, MD research unit 04/UR/08-20
  More Information

No publications provided

Responsible Party: State secretary of research, High education and research ministery
ClinicalTrials.gov Identifier: NCT00791505     History of Changes
Other Study ID Numbers: 04/UR/08-20
Study First Received: November 12, 2008
Last Updated: November 13, 2008
Health Authority: Tunisia: Office of Pharmacies and Medicines

Keywords provided by University of Monastir:
chronic obstructive pulmonary disease
pulmonary infection
antibiotic

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Sepsis
Lung Diseases, Obstructive
Respiratory Tract Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Ciprofloxacin
Fluoroquinolones
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 15, 2014