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

Conditions: Acute exacerbation of chronic bronchitis
MedDRA version: 9.1Level: LLTClassification code 10066548Term: Acute bacterial exacerbation of chronic bronchitis

Registration Number: EUCTR2007-006096-37-IT

Lead Sponsor: BAYER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1786

Inclusion Criteria

1.Outpatients 2.Male or female subjects, >/=60 years old 3.Subject who can be managed with oral antimicrobials 4.FEV1≤50% predicted at enrollment in addition to a historical record of FEV1 of ≤60% within the past 12 months obtained during a stable infection-free period. A historical record of FEV1 is not required if the enrollment FEV1 is less than or equal to 50%. 5.Documented history of 2 or more AECB episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroids 6.All symptoms/signs must be present and confirmed by the Investigator: Increase in dyspnea Purulent sputum Increase in sputum volume 7.Subject must provide a purulent sputum sample by deep expectoration prior to randomization for Gram stain, culture and sensitivity testing. The sputum will be assessed macroscopically by the investigator and graded according to the provided color chart. 8.Current or past cigarette smoker with >/=20 pack year smoking history 9.Subjects must have an infection free interval of at least 30 days prior to enrollment 10.Subjects must be willing and able to complete the questionnaires and subject booklet without assistance 11.Subjects with medical conditions and social status at the time of enrollment compatible with study protocol procedures 12.Willing and able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity to quinolones, ß lactams, or to any of the excipients of the study drugs 2.Known to have congenital or acquired QT prolongation 3.Known to have clinically relevant bradycardia 4.Known to have clinically relevant heart failure with reduced left ventricular ejection fraction 5.Known to have previous history of symptomatic arrhythmias 6.Taking QT prolonging drugs, for example class IA or III antiarrhythmic agents (e.g., quinidine, procainamide, amiodarone, sotalol), neuroleptics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antihistaminics (e.g., terfenadine, astemizole, mizolastine), or other QT prolonging drugs (e.g., cisapride, vincamine iv, bepridil, and diphemanil) 7.Known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia 8.Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption 9.Requiring hemodialysis 10.History of a tendon disease/disorder 11.Known history of liver dysfunction, including known elevated transaminases (ALT and/or AST >3 times the upper limit of normal) 12.Known severe renal impairment with glomerular filtration rate of <30mL/min 13.Known neutropenia (neutrophil count <1000/mm3) caused by immunosuppressive therapy or malignancy 14.Known to have AIDS (CD4 count of <200/mm3), or be HIV positive and receiving Highly Active Anti Retroviral Therapy (HAART) (HIV testing is not mandatory) 15.Known bronchial carcinoma, active pulmonary tuberculosis, known diffuse bronchiectasis, cystic fibrosis, chronic asthma (>15% reversibility), or pneumonia (a chest X ray is not mandatory) 16.Known history of chronic colonization of pathogenic organisms resistant to moxifloxacin and/or amoxicillin clavulanic acid (e.g., Pseudomonas aeruginosa, MRSA) 17.Receiving long term (>4 consecutive weeks) systemic corticosteroid treatment (>10 mg/day of prednisolone or equivalent) (see Section 4.5.7 Prior and Concomitant Medication) 18.Received short course of systemic corticosteroid treatment within 30 days prior to enrollment 19.Requiring intravenous antibiotic therapy for treatment of the current exacerbation 20.Unable to take oral medication 21.Life expectancy of less than 6 months 22.Receiving systemic antibacterial therapy within 30 days prior to study enrollment 23.Requiring concomitant systemic antibacterial agents 24.Use of any investigational drug or device within 30 days of screening, or previously enrolled in this study 25.Requiring home ventilatory support (subjects requiring home/portable oxygen therapy or CPAP for sleep apnea are not excluded) and/or those who have a tracheotomy in situ