EUCTR2008-000412-33-FR进行中（未招募）1 期
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development0 个研究点目标入组 210 人开始时间: 2008年11月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •Male or female subjects =18 years of age known or suspected to have acute HAP.
- •- Acute HAP is defined as pneumonia with onset of symptoms:
- •a. = 48 hours after admission to an acute care hospital or chronic care facility such as a skilled nursing home facility or rehabilitation unit.
- •b. = 7 days after the subject was discharged from the hospital. The initial hospitalization must have been =3 days duration.
- •- VAP is defined as: onset of symptoms of pneumonia = 48 hours after endotracheal intubation.
- •Presence of a new or evolving infiltrate on a chest x-ray film, presence of fever or leukocytosis, respiratory failure requiring mechanical ventilation or presence of 2 of the following clinical signs and symptoms: cough or dyspnea, tachypnea or pleuritic chest pain, rales and/or evidence of pulmonary consolidation, hypoxemia, or purulent sputum production.
- •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
- •Subjects with other significant underlying conditions that would make it difficult to evaluate the subjects or make it unlikely to complete the therapy or that would increase their risk by participating in the study, infection with organisms known to be resistant, contraindications, or hypersensitivity to any of the test articles, known Legionella infection, known Pseudomonas aeruginosa infection, hemodialysis, hemofiltration, peritoneal dialysis, plasmapheresis, presence of sustained shock, Acute Physiologic and Chronic Health Evaluation Scale (APACHE) II score > 30, significant neutropenia, hepatic and/or renal insufficiency, antibacterial drugs administered for > 24 hours before study entry unless resistance demonstrated or no improvement, known human immunodeficiency virus (HIV) infection, pregnant women or nursing mothers.
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