PER-046-06已完成未知
Prospective, Randomized, Double Blind Study to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 days Versus Placebo Versus Telithromycin in the Treatment of Acute Exacerbation of Chronic Bronchitis.
REPLYDINE INC.,0 个研究点目标入组 0 人开始时间: 2006年8月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •a) Outpatients men and women who were not pregnant> 35 years of age with significant COPD, chronic cough and sputum production and acute exacerbation of chronic bronchitis.
- •b) Ex-smokers or smokers and / or present an obstruction in the
- •c) Present a clinical diagnosis of AECB defined as.
- •d) The patient must provide a purulent or mucopurulent sputum by deep expectoration for a culture and susceptibility test on the day of enrollment in the study.
- •e) If a woman, the subject must: 1) Be postmenopausal for at least 1 year, or 2) Have had a hysterectomy and / or bilateral oophorectomy, or 3) Have had a bilateral tubal ligation or otherwise be disabled to get pregnant.
- •f) If the subject is of fertile potential, they must: 1) Have maintained their normal menstrual pattern during the 3 months prior to admission to the study AND 2) have taken hormonal contraceptives for at least 1 month before entering the study, or agree to use a spermicide and barrier methods or use another acceptable method of contraception and agree to continue its use during the study AND 3) Have had a pregnancy test of subunit B of hCG negative.
- •g) The women subjects who will be pregnant during their participation should be withdrawn from the trial immediately.
- •h) Read and sign the Informed Consent and, if applicable, the California Bill of Rights.
- •i) The subject is an appropriate candidate for oral antibacterial therapy.
排除标准
- •a) History of hypersensitivity to faropenem medoxomil or to any of the components of the product or a history of an anaphylactic reaction to beta-lactamases.
- •b) History of hypersensitivity to telithromycin or to any member of the macrolide antimicrobial agents.
- •c) Chest x-ray and other radiographic documentation of an underlying pneumonia.
- •d) Known malignancy of the active thoracic or pulmonary cavity within the last 5 years.
- •e) Known concurrent active medical charts that could interfere with the effectiveness evaluation.
- •f) Neutropenia, or CD4 count <200 cells / mm3 or under highly active antiretroviral therapy (HAART). An HIV test is not necessary.
- •g) Need for hospitalization or administration of intravenous antibiotics because of the present exacerbation.
- •h) Hospitalization for any reason within the two weeks prior to admission to the study, for ≥ 48 hours.
- •i) Any previous treatment of a systemic antibacterial agent within the last 2 weeks.
- •j) Subjects under concomitant therapy with one or more of the following medications: Class lA or Class III antiarrhythmic agents, HMG-CoA reductase inhibitors, rifampin, phenytoin, carbamazepine, phenobarbital, cisapride, pimozide, ergotamine or dihydroergotamine.
- •k) Subjects with heart failure under treatment with metoprolol.
- •l) Subjects with severe renal insufficiency and / or liver failure
- •m) Prior treatment under this Protocol.
- •n) The subject is pregnant or breast-feeding.
- •o) Have received an experimental drug or medical device within the last 30 days.
- •p) Employees and / or family members of the researcher or study center with direct participation in the proposed study or another study under the direction of that researcher or study center.
- •q) Patients with a family or personal history of QTc prolongation or proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, or clinically significant bradycardia.
- •r) Patients with myasthenia gravis.
- •s) Patients with a history of hepatitis / jaundice associated with the use of telithromycin (KETEK)
研究者
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