PHASE lllb, PROSPECTIVE, DOUBLE-BLIND, RANDOM, COMPARATIVE, PARALLEL GROUPS, MULTICENTRIC AND MULTINATIONAL CLINICAL STUDY ABOUT THE EFFECTIVENESS AND SAFETY OF THE TREATMENT OF ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS WITH MOXIFLOXACIN 400 MG OD DURING 5 DAYS VS. LEVOFLOXACIN 500 MG OD DURING 7 DAYS
- Conditions
- -J42 Unspecified chronic bronchitisUnspecified chronic bronchitisJ42
- Registration Number
- PER-037-99
- Lead Sponsor
- BAYER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Adult male or female patients> 18 years old.
• Patients within 7-14 days of onset of their exacerbation of chronic bronchitis.
• Patients with increased production of purulent / mucopurulent sputum.
• Patients with increased cough.
• Patients with mild or moderate dyspnea.
• Patients who have had an appropriate sample taken for culture before the first study drug intake. The Gram stain report should reveal> 25 leukocytes and <10 squamous epithelial cells per expanded field of low power (10x) according to the Group 5 Rating System of Murray-Washington.
• The patient or his legal representative gives written informed consent duly signed.
• Female patients who are pregnant, determined by a rapid urine pregnancy test during the selection stage, during breastfeeding or using an inadequate method of contraception.
• Patients with a history of seizures, probability of developing them, severe traumatic brain injury or within 2 months after a stroke.
• Patients with severe heart failure (NYHA Class IV).
• Patients with confirmation or clinical and / or radiological suspicion of pneumonia, bronchiectasis, cystic fibrosis, tuberculosis or lung cancer.
• Patients with hepatic impairment in level C of the Child-Pough Classification.
• Patients with confirmed, known or suspected impairment of renal function (creatinine> 265 umol / L [3.0 mg / dL]) or in a dialysis program.
• Patients with neutropenia due to cancer or chemotherapy (absolute neutrophil count <1000 cells / mL).
• Patients with AIDS (definition according to the CDC: CD4 count <200 cells / mm ^) - HIV-positive patients can be included. No HIV test is required for this study.
• Patients with congenital or acquired QT prolongation syndrome known or who are receiving concomitant medication known to increase the QT interval. for example, amiodarone, sotalol, disopyramide, quinidine, procainomide, torfenadine.
• Patients with another concurrent acute infectious disease that requires concomitant systemic antibiotics.
• Patients who have received a systemic antibiotic for more than 24 hours during the two weeks prior to its inclusion. It can include a patient who has had a clear failure to previous antibacterial treatment, unless he has received a fluoroquinolone.
• Patients with a history of allergy to fluoroquinolones or related components.
• Patients with a history of tendinopathy associated with fluoroquinolones.
• Patients previously included in this study.
• Patients who have participated in a clinical study in the last 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Two-way 95% confidence intervals will be calculated for the differences of the two pairs of clinical success rates (clinical success rates of Moxifloxacin minus Levofloxacin) using the Mantel-Haenszel test.<br><br>Measure:Efficacy (Clinical Response)<br>Timepoints:7 to 14 days after finishing the treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Physical exams and laboratory tests. The incidence and severity of adverse events and values will be compared<br>Abnormal laboratory between both groups.<br>Measure:Safety<br>Timepoints:During the study<br>;<br>Outcome name:A bacteriological failure is a patient with a bacteriological response of persistence or superinfection during treatment, a bacteriological success is a patient with a bacteriological response of eradication or presumptive eradication without the presence of superinfection.<br>Measure:Efficacy (Bacteriological Response)<br>Timepoints:During the study and from 7 to 14 days after the study<br>