Randomized, double-blind, multicenter, comparative, Phase III study with BMS-284756 oral vs. oral clarithromycin in the treatment of community-acquired pneumonia.

BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2000年10月16日最近更新: 2023年9月4日

试验速览

阶段: 未知
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•Men or women 18 years of age or older, in whom oral therapy is indicated, with clinical evidence of community-acquired pneumonia.
•The subject or his legally authorized representative have granted written informed consent
•Women of childbearing age (MEF) must have a negative pregnancy test in serum or urine (minimum sensitivity of 25 IU / L or equivalent units of HCG) made within 48 hours immediately prior to the start of study drug administration .

排除标准

•Subjects who have received more than a single dose of any systemic antibiotic (or a single dose of a combination of antibiotics, such as a cephalosporin plus a macrolide) within 7 days immediately prior to admission, or who may receive other systemic antibiotics during your participation in the study;
•Subjects who, in the opinion of the Investigator, will require long-term antibacterial therapy (ie, for more than 10 days) or hospitalization to receive intravenous therapy to treat the underlying infection;
•Subjects with previously diagnosed conditions that tend to imitate or complicate the course and evaluation of the infectious process (for example, known bronchial obstruction in addition to asthma or COPD, history of postobstructive pneumonia, cystic fibrosis, active lung malignancy);
•Known active tuberculosis or suspected active tuberculosis, or infection with other mycobacteria or fungi;
•Pneumonia known or suspected of Pneumocystis carinii pneumonia;
•Previously diagnosed disease or diseases of immune function (eg, AIDS, current neutrophil count <1000 / mm3);
•Current known, clinically significant liver disease, or levels of ALT and / or AST and / or total bilirubin> 3 times the normal maximum limit;
•Subjects receiving chronic systemic steroids (ie,> 2 weeks) at a dose of> 10 mg prednisone per day (or its equivalent), or other chronic immunosuppressive therapy;
•Known renal insufficiency (eg, serum creatinine> 2.0 mg / dL (176.7 pmoI / L) or requiring renal dialysis;
•Subjects with empyema;
•Subjects with primary lung abscess;
•Infection acquired in a hospital, asylum or other institution of long-term care, or hospitalization for any reason in the previous 14 days;
•History of serious hypersensitivity reaction (eg, urticaria, anaphylaxis) to any quinolone or macrolide compound;
•Subjects receiving terfenadine, cisapride or astemizole;
•Malabsorption syndromes or other gastrointestinal disorders that could affect the absorption of the medication;
•Use of a research agent concomitantly or within 30 days prior to admission in this study;
•Have been previously admitted to any study with BMS-284756;
•Pregnancy and / or lactation; Y
•Presence of any disorder or disease that may interfere with the evaluation of the study medication and / or due to which, in the opinion of the Investigator, it would not be appropriate to admit the subject in the study;

研究者

发起方

BRISTOL MYERS SQUIBB PERU S.A.,

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