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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791505
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : February 24, 2020
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Mechanical ventilation duration [ Time Frame: 30 days after starting protocol ]
    duration of mechanical ventilation

  2. Duration of hospital stay [ Time Frame: 30 days after starting protocol ]
    duration of hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00791505

Sponsors and Collaborators
University of Monastir
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Principal Investigator: nouira semir, MD research unit 04/UR/08-20
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pr. Semir Nouira, MD Semir Nouira, University of Monastir Identifier: NCT00791505    
Other Study ID Numbers: 04/UR/08-20
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Keywords provided by Pr. Semir Nouira, University of Monastir:
chronic obstructive pulmonary disease
pulmonary infection
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Nucleic Acid Synthesis Inhibitors