None listed
Conditions
Interventions
Group 1 Type of group
400 mg of moxifloxacin PO OD for five days
Group name:Group 2 Type of group
Amoxicillin - clavuicanic acid 875/125 mg PO BID for seven days
Sponsors
BAYER S.A.,
Eligibility
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Ambulatory • Male or female patients,> 60 years of age • Patients who can be treated with oral antimicrobials • FEV1 20 packages per year. • Patients must have an infection-free interval of at least 30 days before enrollment • Patients must accept and be able to complete the questionnaires and the patient´s booklet without assistance. • Patients with medical conditions and social status at the time of enrollment compatible with the procedures of the study protocol • Accept and be able to provide written informed consent.
Exclusion criteria
Exclusion criteria: • Known hypersensitivity to quinolones, b-lactams or to any of the excipients of the drugs under study. • Prolongation of known congenital or acquired QT • Clinically relevant known bradycardia. • Clinically relevant known heart failure with reduction of left ventricular ejection fluction • Known antecedents of previous symptomatic arrhythmias • Intake of drugs that prolong the QT, for example antiarrhythmic agents class IA or III for ex. quinidine, procainamide, amiodarone, sotalol), neuroleptics (eg phenothiazine, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antihistamines (eg terfenadine, astemizole, mizolastine), or other medications that prolong QT (eg cisapride, vincamine iv, bepridil, and diffemanil). • Known electrolyte alterations that are not controlled, particularly hypokalemia without correction • Known hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption • Hemodialysis requirement • History of disease / tendon disease • Known history of hepatic dysfunction, including knowledge of transaminase elevation (ALT and / or AST> 3 times the upper normal limit) • Known severe renal insufficiency with a glomerular filtration rate of 15%), or pneumonia (radiography is not mandatory). • Known antecedents of chronic colonization of pathogenic organisms resistant to moxifloxacin and / or amoxicillin - clavulanic acid (eg Pseudomonas aeruginosa, MRSA) • Long-term treatment received (> 4 consecutive weeks) with systemic corticosteroids (> 10 mg / day of prednisolone or equivalent) • Have received a brief treatment of systemic corticosteroids within 30 days of enrollment • Require intravenous antibiotic treatment for the treatment of the current exacerbation • Inability to take oral medication • Life expectancy less than 6 months • Receive systemic antibacterial treatment within 30 days prior to enrollment in the study • Require concomitant systemic antibacterial agents • Use of any medication or experimental device within 30 days of selection or previously enrolled in this study • Require home ventilatory support (patients requiring portable / home treatment with oxygen or CPAP for sleep apnea are not excluded) and / or those who have tracheostomy in situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical failure will be defined as the requirement for additional systemic antibiotics and / or steroid steroids and / or hospitalization (including increased dose or duration of treatment) for any respiratory event within 8 weeks after treatment. Measure:Clinical failure within 8 weeks after treatment Timepoints:8 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The clinical response will be based on serial examinations of the patient to determine the effect of treatment on the findings of auscultation, chest pain / discomfort, cough frequency, dyspnea, sputum purulence, sputum consistency and volume of sputum Measure:Clinical efficacy indices at visits during Treatment, EOT, and 4 weeks After treatment Timepoints:During Treatment, EOT, and 4 weeks After treatment ; Outcome name:Bacteriological eradication: absence of the initial causative agent Measure:Bacteriological eradication index in visits During Treatment, EOT, 4 weeks After treatment and 8 weeks After treatment Timepoints:During Treatment, EOT, 4 weeks After treatment and 8 weeks After treatment ; Outcome name:The clinical response will be based on serial examinations of the patient to determine the effect of treatment on the findings of auscultation, chest pain / discomfort, cough frequency, dyspnea, sputum purulence, sputum consistency and volume of sputum Measure:Clinical efficacy for patients with positive culture of sputum at enrollment, during visits During Treatment, EOT, 4 weeks After treatment and 8 weeks After treatment Timepoints:during visits During Treatment, EOT, 4 weeks After treatment and 8 weeks After treatment ; Outcome name:The patient will complete the BABC-SS, a symptom assessment instrument to evaluate changes in BABC symptoms reported by the patient, on a daily basis from the beginning of treatment with study medication to the EOT visit. Measure:Average score of weekly symptoms measured through the EABC-SS Timepoints:Until the EOT visit. ; Outcome name:The patient will complete the BABC-SS, a symptom assessment instrument to evaluate changes in BABC symptoms reported by the patient, on a daily basis from the beginning of treatment with study medication to the EOT visit. Measure:Index and rate of relief of symptoms measured by the EABC-SS Timepoints:Until the EOT | — |
Countries
Czech Republic, Greece, Ireland, Italy, Latovia, Lithuania, Netherlands, Portugal, Spain, United Kindgdom
Contacts
Public ContactLuis Carlos Razzeto
BAYER S.A.
Outcome results
None listed