A prospective, multicenter study to investigate the pharmacokinetics, safety, and efficacy of cadazolid versus vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea.

Actelion Pharmaceuticals Ltd.0 个研究点目标入组 200 人开始时间: 2017年4月11日最近更新: 2018年8月20日

试验速览

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•Parts A and B:
•- Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure.
•- Male or female from birth to < 18 years.
•- Subject is diagnosed with CDAD
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 200
•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

•Parts A and B:
•- Positive Rotavirus test for subjects < 5 years.
•- Fulminant or life-threatening CDAD
•- More than one previous episode of CDAD in the 3 month period prior to enrolment/randomization.
•- Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF).
•- Subjects with body weight < 3 kg.
•- Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology.
•- Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug to prevent or treat CDAD within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrolment/randomization.
•- Monoclonal antibodies against C. difficile within 6 months prior to enrolment/randomization.
•- Previous vaccination against C. difficile.
•- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject’s full participation in the study, or compliance with the protocol.

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