None listed
Conditions
Interventions
Group 1 Type of group
Moxifloxacin 400 mg po od during a period of 5 days.
Group name:Group 2 Type of group
Levofloxacin 500 mg po od for a period of 7 days.
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Efficacy (Clinical Response) Timepoints:7 to 14 days after finishing the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Physical exams and laboratory tests. The incidence and severity of adverse events and values will be compared Abnormal laboratory between both groups. Measure:Safety Timepoints:During the study ; 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. Measure:Efficacy (Bacteriological Response) Timepoints:During the study and from 7 to 14 days after the study | — |
Outcome results
None listed