PER-078-13已完成未知
A MULTICENTER, RANDOMIZED, DOUBLE-BLINDED COMPARATIVE STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF DAPTOMYCIN VERSUS ACTIVE COMPARATOR IN PEDIATRIC SUBJECTS WITH ACUTE HEMATOGENOUS OSTEOMYELITIS DUE TO GRAM-POSITIVE ORGANISMS
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 1 至 18（—）
- 性别
- All
入选标准
- •Subjects are required to meet ALL of the following inclusion criteria:
- •1. Informed consent in writing from parent(s) or legally-acceptable representative(s) and, informed assent from subject (if age appropriate according to local requirements)
- •2. Male or female, 1 year to < 18 years old (subject must be randomized before 18th birthday)
- •3. Presence of AHO warranting hospitalization and IV antibacterial therapy
- •Additional information is described in the Protocol
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •1. Documented history of any hypersensitivity or allergic reaction to daptomycin, vancomycin, or any β-lactam antibacterial agent
- •2. Diagnosis of contiguous septic arthritis associated with AHO at baseline
- •3. AHO of the spine or pelvis or AHO involving multiple locations (2 or more bones)
- •4. Chronic osteomyelitis or symptoms of osteomyelitis exceeding 14 days
- •Additional information is described in the protocol
研究者
相似试验
已完成
不适用
A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, COMPARATIVE PHASE III STUDY OF ORAL BMS-284756 VERSUS ORAL AZITHROMVCIN IN THE TREATMENT OF ACUTE EXACERBATION OF CHRONIC BRONCHITIS-J42 Unspecified chronic bronchitisUnspecified chronic bronchitisJ42PER-066-00BRISTOL MYERS SQUIBB PERU S.A.,
进行中（未招募）
不适用
A study to find out whether maraviroc given once daily is as effective as Truvada given once daily in treating HIV-infected patients never previously treated with maraviroc.EUCTR2010-021785-30-ITVIIV HEALTHCARE UK LIMITED804
进行中（未招募）
不适用
A study to find out whether maraviroc given once daily is as effective as Truvada given once daily in treating HIV-infected patients never previously treated with maraviroc.HIV infectionMedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2010-021785-30-PTViiV Healthcare UK Limited804
进行中（未招募）
不适用
A study to find out whether maraviroc given once daily is as effective as Truvada given once daily in treating HIV-infected patients never previously treated with maraviroc.HIV infectionMedDRA version: 14.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-021785-30-FIViiV Healthcare UK Limited804
进行中（未招募）
不适用
A study to find out whether maraviroc given once daily is as effective as Truvada given once daily in treating HIV-infected patients never previously treated with maraviroc.EUCTR2010-021785-30-DEViiV Healthcare UK Limited804