A prospective, multinational, multicenter, randomized, double-blind, double-dummy, controlled study comparing the efficacy and safety of moxifloxacin to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbations of chronic bronchitis: MAESTRAL (moxifloxacin in AECB superiority trial) - MAESTRA

Not Applicable

Conditions: -J42 Unspecified chronic bronchitis
Unspecified chronic bronchitis
J42

Registration Number: PER-043-08

Lead Sponsor: BAYER S.A.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Ambulatory
• Male or female patients,> 60 years of age
• Patients who can be treated with oral antimicrobials
• FEV1 <50% of the foreseen in the enrollment. In addition, if you have a record of FEVi within the last 12 months obtained during a period free of infection, this historical FEVi should also be <60%. The historical record of FEV1 is not required if less than or equal to 50%.
• Documented history of 2 or more episodes of BABC within 12 months of study enrollment, which required a course of systemic antibiotics and / or systemic corticosteroids
• All symptoms / signs must be presented and confirmed by the Investigator: Increased dyspnea, Purulent sputum, Increased sputum volume
• The patient should provide a sample of purulent sputum by deep expectoration before randomization for Gram stain, culture and sensitivity test. The investigator will evaluate the sputum macroscopically and classify it as purulent according to the color chart provided.
• Current or past smoker with smoking history> 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

• 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 <30 ml / min
• Known neutropenia (neutrophil count • Known diagnosis of AIDS (CD4 count <2D0 / inm3), or being HIV positive treated with HAART (HIV test is not mandatory)
• Known diagnoses of bronchial carcinoma, active pulmonary tuberculosis, diffuse bronchiectasis, cystic fibrosis, chronic asthma (reversibility> 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>Measure:Clinical failure within 8 weeks after treatment<br>Timepoints:8 weeks after treatment<br>

Secondary Outcome Measures

Name	Time	Method

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