This is a multinational research study comparing liquid or tablets of medicine Fidaxomicin versus liquid or capsules of medicine Vancomycin in children having Diarrhea caused with bacteria named Clostridium difficile
- Conditions
- MedDRA version: 18.0Level: LLTClassification code 10012734Term: Diarrhea, Clostridium difficileSystem Organ Class: 100000004862Treatment of enterocolitis caused by Clostridium difficileTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-000508-40-HU
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 144
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 aged from birth to < 18 years of age. Note that in the United States of America subjects can only be included if aged = 6 months to < 18 years.
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: 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules of pediatric subjects with Clostridium difficile-associated diarrhea (CDAD) from birth to < 18 years of age.;Secondary Objective: The secondary objectives of this study are to investigate the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD) from birth to < 18 years of age, as well as acceptance of the fidaxomicin oral suspension formulation.;Primary end point(s): Confirmed clinical response based on the assessment by the investigator at EOT+2 days TC/visit;Timepoint(s) of evaluation of this end point: at EOT+2 days TC/visit
- Secondary Outcome Measures
Name Time Method