EUCTR2006-003944-42-BG进行中（未招募）不适用
Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo in the Treatment of Acute Exacerbation of Chronic Bronchitis”
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 611
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
- •a. Male or non-pregnant female outpatients age = 35 years with significant COPD (GOLD criteria I, II or III), chronic cough and sputum production and an acute exacerbation of chronic bronchitis;
- •b. have a history (past or current) of smoking (= 10 pack-years);
- •c. Have evidence of airflow obstruction (within a year prior to the current exacerbation or during the current exacerbation and then reconfirmed after recovery), defined as:
- •- Forced expiratory volume in one second (FEV1) % predicted = 35 years and
- •- Ratio of FEV1 to forced capacity (FVC) of 0.70
- •d. Have a clinical diagnosis of AECF defined as:
- •- Cough and sputum production on most days for at least 3 consecutivemonths for > 2 successive years
- •- All of the following cardinal symptoms must be present:
- •* Increase in or worsening of cough
- •* Increase or worsening of dyspnea
- •* Increase in sputum volume
- •* Increase in sputum purulence
- •e. Patient must provide a purulent or muco-purulent sputum by deep expectoration for culture and susceptibility testing on the day of study enrollment;
- •f. If female, the subject must:
- •- be postmenopausal for at least 1 year, OR
- •- have had a bilateral oophorectomy and/or hysterectomy, OR
- •- have had a bilateral tubal ligation or otherwise be incapable of pregnancy, OR
- •g. if of childbearing potential, the subject must:
- •- have maintained her normal menstrual pattern duting the 3 months prior to study entry, AND
- •- have taken hormonal contraceptives for at least 1 month prior to study entry, or agree to use spermicide and barrier methods or have been using another acceptable method of contraception and agree to continue with the same method during the study, AND
- •- have had a negative urine ß- subunit hCG pregnancy test sensitive to at least 50 µU/mL of ß-hCG immediately prior to study entry;
- •h. female subjects who become pregnant during participation must be promptly withdrawn from the trial
- •The subject is to be withdrawnfrom the study if the urine pregnancy test is positive;
- •i. Read and sign the Informed Consent
- •j. Subject is an appropriate candidate for oral antibacterial therapy
- •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
- •a. History of hypersensitivity to faropenem medoxomil or any of the components of the product or a history of an anaphylactic reaction to ß-lactams (e.g., penicillins or cephalosporins);
- •b. Chest x-ray or other radiographic documentation of an underlying pneumonia;
- •c. Known lung or chest cavity malignancy active within the past 5 years;
- •d. Known concurrent medically active conditions likely to interfere with the evaluation of efficacy (e.g., pulmonary tuberculosis, bronchiectasis, cystic fibrosis, etc.)
- •e. Known neutropenia (< 1000 cells/mm3), or CD4 count of < 200 cells/mm3, or on highly active antiretroviral therapy (HAART). An HIV test is not required;
- •f. The need for hospitalization or intravenous antibiotics for this exacerbation;
- •g. Hospitalization for any cause within two weeks prior to study entry, lasting = 48 hours;
- •h. Any previous course of a systemic antibacterial agent within the last 2 weeks;
- •i. Subject has severe renal insufficiency (CrCl < 30 mL/min) and/or severe hepatic insufficiency (Childs-Pugh Class C);
- •j. Previous treatment under this Protocol;
- •k. Subject is pregnant or breastfeeding;
- •l. Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period);
- •m. Employees and/or family members of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.
- •Subjects will be enrolled before the results of clinical and microbiological laboratory results are available.
研究者
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