EUCTR2004-001412-30-HU进行中（未招募）不适用
An open-label, randomized, multicenter, clinical study to comparethe effects of telithromycin, azithromycin and cefuroxime axetilon the penicillin or macrolide resistance of Streptococcus pneumoniaein patients with acute exacerbation of chronic bronchitis - Perspective
aboratoire Aventis0 个研究点目标入组 5,660 人开始时间: 2005年9月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,660
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
- •Patients meeting all of the following criteria will be considered for enrollment into the study:
- •·Outpatients, male or female, aged 35 years or older
- •·Patient with a documented history of chronic bronchitis, characterized by cough and excessive sputum production for most days of at least three months for 2 consecutive years,
- •·Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis, presumed due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume;
- •·Patients producing spontaneous sputum;
- •·Patients with three or less AECB in the previous 12 months
- •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
- •·Patients with a known diagnosis of bronchiectasis, cystic fibrosis, lung cancer or lung metastases, active pulmonary tuberculosis or with suspected pneumonia;
- •·Patients with present acute respiratory failure or patients requiring aggressive airway management;
- •·Hospitalized patients and patients from institutional care facilities;
- •·Patients treated with antibiotics within 14 days prior to enrollment;
- •·Patients who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety;
- •·Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results difficult;
- •·Patients with a progressively fatal disease, or life expectancy = three months;
- •·Patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period;
- •·Patients with a recent (within the previous three months) history of alcohol or drug abuse;
- •·Immunocompromised patients including but not limited to: Patients with known HIV infection (CD4 + <200/mm3), known neutropenia (<1500 neutrophils/mm3), chronic corticosteroid therapy (³ 10mg/day prednisolone equivalent during at least three months), immunodepressant treatment within the previous six months, splenectomized patients or patients with known hyposplenia or asplenia;
- •·Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study;
- •·Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study;
- •·Patients having received anti-pneumococcal immunization in the previous six months before study entry;
- •·Patients with suspected or known hypersensitivity to, or suspected serious adverse reaction to the study medication, or to ß-lactams or macrolides classes of antibiotics;
- •·Patients diagnosed with myasthenia gravis;
- •·Women who are breast-feeding or who are pregnant;
- •·Women who are of childbearing potential who do not agree to use an approved contraceptive method during the study;
- •·Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
- •·Patients with a known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia);
- •·Patients treated within 2 weeks prior to study entry, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicin, phenytoïn, carbamazepine, phenobarbital, and St John’s Wort;
- •·Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol (see section 6.2);
- •·Patients known to have impaired hepatic function;
- •·Patients known to have impaired renal function;
- •·Patients already enrolled in this study
研究者
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