A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria

Bronchitis Clinical Trial

Official title:

A Multicenter, Active-Controlled, Randomized Study to Evaluate the Safety and Efficacy of Oral Levofloxacin Versus Cefaclor in the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257140
• Other study ID #: CR005494
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 18, 2005
• Last updated: June 8, 2011
• Start date: June 1931
• Est. completion date: July 1994

Study information

• Verified date: January 2011
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

Description:

This is a randomized, open-label, parallel group, multicenter study to determine the effectiveness and safety of 488 mg of levofloxacin (once daily by mouth for 5 - 7 days) compared with 250 mg of cefaclor (every 8 hours for 7 - 10 days) in adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacterial infection. The study consists of 3 visits: one visit for screening and enrollment, and 2 visits for assessment of safety and effectiveness (one visit on Days 3 - 5 of the study and one visit [post-therapy] 5 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. Levofloxacin and cefaclor are antibacterial agents used for the treatment of many types of infections, including infections with a rapid onset and brief duration caused by bacteria. The primary assessment of effectiveness in this study is the microbiologic response to treatment (the rate of elimination of disease-causing bacteria, by patient, and by type of bacteria), 5 - 7 days after the last dose of study drug. Safety evaluations (incidence of adverse events, physical examination, laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with cefaclor in adult patients with chronic bronchitis experiencing sudden worsening of symptoms caused by bacterial infection. Levofloxacin 488 mg by mouth once daily for 5 - 7 days, or cefaclor 250 mg by mouth every 8 hours for 7 - 10 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: July 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of chronic bronchitis with a rapid onset of worsening of symptoms caused by bacteria

• history of chronic obstructive lung disease (chronic bronchitis and/or emphysema)

• recent increase in cough

• change in type of sputum (the mucus produced on coughing) and/or an increase in the production of sputum

• received previous antibiotic treatment if the previous treatment lasted for 24 hours or less, or if the previous treatment lasted longer than 24 hours but there was no improvement or stabilization of the disease.

Exclusion Criteria:

• Illness requiring antibiotic treatment by injection into a vein, beneath the skin, or into a muscle, or has a requirement of an antibiotic medication taken orally in addition to the study drug

• infection due to bacteria known (prior to the start of the study) to be resistant to the study drug

• previous allergic or serious adverse reaction to similar antibiotics

• diagnosis of pneumonia, determined by a chest x-ray at the start of the trial

• has cystic fibrosis, seizure disorders, kidney disease, or an unstable psychiatric condition.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic

Intervention

Drug:
• levofloxacin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	PriCara, Unit of Ortho-McNeil, Inc.

References & Publications (1)

Habib MP, Gentry LO, et al. Multicenter, randomized study comparing efficacy and safety of oral levofloxacin and cefaclor in treatment of acute bacterial exacerbations of chronic bronchitis, Infectious Diseases in Clinical Practice 1998;7:101-109

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of elimination of disease-causing bacteria, by patient, and by type of bacteria, 5 - 7 days after the last dose of study drug.
Secondary	Clinical response rate (reduction in signs and symptoms) at post-therapy (5 - 7 days after the last dose of study drug). Incidence of adverse events; changes in physical examination and laboratory tests after treatment with the study drug.

External Links

•   A study of the safety and effectiveness of levofloxacin compared to cefaclor in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria