A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Condition: Clostridium Difficile-associated Diarrhea (CDAD)
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Fidaxomicin oral suspension; Fidaxomicin tablets; Vancomycin oral liquid; Vancomycin capsules
Intervention description: Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days.; Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.; Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days.; Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
Intervention MeSH terms: Vancomycin; Fidaxomicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 148.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Clostridium difficile-associated Diarrhea (CDAD); vancomycin; Clostridium difficile infection; fidaxomicin

Summary:

      The purpose of this study was to investigate the clinical response to fidaxomicin oral
      suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with
      Clostridium difficile-associated diarrhea (CDAD). It also investigated the
      recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well
      as acceptance of the fidaxomicin oral suspension formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

               -  Subject from Birth to < 2 years: watery diarrhea in the 24 hours prior to
                  screening.

               -  Subject ≥ 2 years to < 18 years: ≥ 3 unformed bowel movements in the 24 hours
                  prior to screening.

               -  Male and female subjects aged from birth to < 18 years: Note that in the United
                  States of America subjects can only be included if aged ≥ 6 months to < 18 years.

          -  For subjects < 5 years: Negative rotavirus test.

          -  Female subject of childbearing potential:

               -  must have a negative urine pregnancy test at Screening, and

               -  must abstain from sexual activity for the duration of the study, or

               -  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.

          -  Female subject must not be breastfeeding at Screening or during the study period, and
             for 28 days after the final study drug administration.

          -  Female subject must not donate ova starting at Screening and throughout the study
             period, and for 28 days after the final study drug administration.

          -  Subject agrees not to participate in another interventional study while in the study
             (with the exception of studies as described in exclusion criteria below).

        Exclusion Criteria:

          -  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.

          -  Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.

          -  Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or
             Crohn's disease etc.).

          -  Subject has diarrhea caused by an agent other than C. difficile (e.g. infections,
             infestations, drugs etc.).

          -  Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or
             to teicoplanin.

          -  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.