Treatment of enterocolitis caused by Clostridium difficile MedDRA version: 18.0 Level: LLT Classification code 10012734 Term: Diarrhea, Clostridium difficile System Organ Class: 100000004862
Conditions
Interventions
Product Name: fidaxomicin
Product Code: fidaxomicin
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: FIDAXOMICIN
CAS Number: 873857-62-6
Current Sponsor code: FIDAXOMICIN
Other d
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 6 months to 3 unformed bowel movements in the 24 hours prior to screening. 4. For subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) aged = 6 months to < 18 years.;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) aged = 6 months to < 18 years, 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy - Sustained clinical response at the EOS (EOT visit+30 days) - Sustained clinical response 14 days after Confirmation Clinical Response TC/visit (EOT visit+16 days) - Time to resolution of diarrhea (TTROD) - Recurrence of CDAD during or at the end of the Follow-up period - Time to recurrence during or at the end of the Follow-up period Safety: The safety evaluation will include adverse events, clinical laboratory tests (hematology, biochemistry and urinalysis), vital signs and ECGs.;Timepoint(s) of evaluation of this end point: Efficacy - EOS (EOT visit+30 days) - EOT visit+16 days - Throughout the study including follow up period Safety - daily assesments: -2,1,2-4,5-10,10, EOT+2, EOT+9, 16&23, EOT+30 | — |
Countries
Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovakia, Spain, United States
Contacts
Public ContactService Desk - Gobal Clinical Dev't
Astellas Pharma Europe B.V.
Outcome results
None listed