EUCTR2013-000508-40-SK进行中（未招募）1 期
A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects with Clostridium difficile-associated Diarrhea
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 148
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
- •1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent/ assent ( if applicable) and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •2. Male and female subjects from birth to < 18 years of age.
- •3.Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum there must be positive detection, within 72 hours prior to randomization, of either toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in stool and:
- •a.Subject from birth to < 2 years of age: watery diarrhea in the 24 hours prior to screening.
- •b.Subject = 2 years to < 18 years: > 3 unformed bowel movements in the 24 hours prior to screening.
- •4. For subjects < 5 years: Negative rotavirus test.
- •5. Female subject of childbearing potential:
- •a. must have a negative urine pregnancy test at Screening, and
- •b. must abstain from sexual activity for the duration of the study, or
- •c. must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
- •6. Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
- •7. Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
- •8. Subject agrees not to participate in another interventional study while in the study (with the exception of studies as described in exclusion criteria 6).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 144
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments for CDAD. If the investigator feels the clinical imperative is to begin treatment before knowing the laboratory result for toxigenic C. difficile, up to four doses but no more than 24 hours of treatment with metronidazole, oral vancomycin or any other effective treatment for CDAD are allowed.
- •2. Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.
- •3. Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or Crohn?s disease etc.).
- •4. Subject has diarrhea caused by an agent other than C. difficile (e.g. infections, infestations, drugs etc.).
- •5. Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or to teicoplanin.
- •6. Subject has received an investigational therapy within 28 days, prior to Screening, with the exception of studies with primary treatment for cancer without novel Investigational Medicinal
- •Product (IMP) and which do not affect the assessment of diarrhea.
- •7. Subject has a condition which, in the investigator?s opinion, makes the subject unsuitable for study participation.
研究者
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