A Study of the Safety & Effectiveness of Levofloxacin Compared With

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00257140
Study type	Interventional
Source	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 1931
Completion date	July 1994

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04016051` - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections	Phase 3
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Recruiting	`NCT02913365` - Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis	N/A
Completed	`NCT01033799` - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers	N/A
Completed	`NCT00350987` - Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study	N/A
Completed	`NCT00250679` - Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease	Phase 3
Completed	`NCT00371527` - Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease	N/A
Completed	`NCT00042718` - A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis.	Phase 3
Completed	`NCT02902640` - A Non-Interventional Safety Study of Balsamic Bactrim	N/A
Completed	`NCT02879981` - A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis
Recruiting	`NCT04144699` - Clinical Validation of Omron WheezeScan
Recruiting	`NCT03320382` - Multiple Breath Washout, a Clinimetric Dataset
Recruiting	`NCT04415827` - Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases	N/A
Completed	`NCT01354938` - Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis	N/A
Completed	`NCT03535558` - Fluoroquinolone Associated Disability
Recruiting	`NCT05330637` - Study on the Influence of Climatic and Environmental Factors on Respiratory Diseases in Sanya, Hainan Province, China.
Completed	`NCT01240174` - Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis	N/A
Completed	`NCT01108185` - Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection	N/A
Completed	`NCT00011310` - Cardiopulmonary Effects of Particulate Exposure	N/A
Completed	`NCT00415753` - Procalcitonin as a Marker of Bacterial Pneumonia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms