A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis.
1 other identifier
interventional
659
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of four oral antibiotic treatment regimens for bacterial infections in patients with chronic bronchitis. The study goals are to demonstrate that 1) levofloxacin 750 mg once daily for three days is no worse than azithromycin 250 mg twice a day for one day and then 250 mg once a day for four more days, and 2) levofloxacin 750 mg once daily for five days is no worse than amoxicillin/ clavulanate (875/125 mg) twice daily for 10 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 5, 2002
CompletedFirst Posted
Study publicly available on registry
August 7, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedApril 28, 2010
April 1, 2010
August 5, 2002
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response rates based on signs and symptoms at posttherapy visit.
Secondary Outcomes (1)
Microbiologic eradication rates at posttherapy visit
Interventions
Eligibility Criteria
You may qualify if:
- History of chronic bronchitis
- Diagnosis of Type-1 or Type-2 acute bacterial exacerbation (worsening) of chronic bronchitis (ABECB) with at least the presence of both increased sputum production and increased sputum purulence with evidence of inflammatory cells
- If female, must be postmenopausal, surgically sterile, or practicing an effective method of birth control
You may not qualify if:
- Diagnosis of bronchial asthma
- Allergy or serious adverse reaction to any of the study medications or other antibiotics
- Failed treatment for pneumonia or acute bacterial exacerbation (worsening) of chronic bronchitis ABECB in three months prior to enrollment in the study with any of the study medications or other antibiotics
- Can not tolerate medication taken by mouth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Kahn JB, Khashab M, Ambruzs M. Study entry microbiology in patients with acute bacterial exacerbation of chronic bronchitis in a clinical trial stratifying by disease severity. Curr Med Res Opin. 2007 Jan;23(1):1-7. doi: 10.1185/030079907X159515.
PMID: 17261234DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 5, 2002
First Posted
August 7, 2002
Study Start
November 1, 2001
Study Completion
August 1, 2003
Last Updated
April 28, 2010
Record last verified: 2010-04