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

NCT00791505 | Completed Phase 3

• 1 other identifier: 04/UR/08-20
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease; Sepsis; Antibiotics

Keywords

chronic obstructive pulmonary disease; pulmonary infection; antibiotic

Outcome Measures

Primary Outcomes (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.

  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

  30 day after starting protocol

Secondary Outcomes (2)

• Mechanical ventilation duration

  30 days after starting protocol

• Duration of hospital stay

  30 days after starting protocol

Study Arms (2)

Ciprofloxacin

ACTIVE COMPARATOR

750 mg a day during 10 days

Drug: ciprofloxacin

trimethoprim-sulfamethoxazole

ACTIVE COMPARATOR

2000 mg a day for 10 days

Drug: trimethoprim-sulfamethoxazole

Interventions

ciprofloxacin DRUG

1500 mg a day for 10 days

Also known as: fluoroquinolone

Ciprofloxacin

trimethoprim-sulfamethoxazole DRUG

2000 mg a day for 10 days

Also known as: sulfatrim, bactrim

trimethoprim-sulfamethoxazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pneumonia documented with chest radiography
• Antibiotic treatment in the ten previous days of ICU admission
• 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

Sponsors & Collaborators

• University of Monastir: lead

Related Publications (1)

• Nouira S, Marghli S, Besbes L, Boukef R, Daami M, Nciri N, Elatrous S, Abroug F. Standard versus newer antibacterial agents in the treatment of severe acute exacerbation of chronic obstructive pulmonary disease: a randomized trial of trimethoprim-sulfamethoxazole versus ciprofloxacin. Clin Infect Dis. 2010 Jul 15;51(2):143-9. doi: 10.1086/653527.

  PMID: 20536364 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sepsis

Interventions

Ciprofloxacin; Fluoroquinolones; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• nouira semir, MD

  research unit 04/UR/08-20

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Semir Nouira

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 14, 2008
• Study Start: July 1, 2002
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: February 24, 2020

Record last verified: 2020-02