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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
NCT00350987 -
Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study
|
N/A | |
Completed |
NCT01033799 -
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
|
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 |