EUCTR2007-006096-37-ES进行中（未招募）不适用
Ensayo clínico prospectivo, multinacional, multicéntrico, aleatorizado, doble ciego, doble simulación, que compara la eficacia y la seguridad de moxifloxacino respecto a amoxicilina/ácido clavulánico en el tratamiento de pacientes con exacerbaciones agudas de bronquitis crónica”Estudio MAESTRAL. (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
Bayer HealthCare AG, Leverkusen, Germany0 个研究点目标入组 1,786 人开始时间: 2008年4月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,786
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Outpatients
- •2.Male or female subjects, greater than or equal to 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 great than or equal to 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
排除标准
- •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 greater than 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)
- •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
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