Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
Condition: Clostridium Difficile-Associated Diarrhea (CDAD)
MeSH terms: Clostridium Infections; Diarrhea
Intervention: fidaxomicin; Placebo
Intervention description: Fidaxomicin 200 mg tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Study drug treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).
Study drug treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days.; Placebo tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).
Treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days.
Intervention MeSH terms: Fidaxomicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 611.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; Clostridium difficile-Associated Diarrhea; Prophylaxis; Hematopoietic Stem Cell Transplantation

Summary:

      The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus
      placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult
      participants undergoing hematopoietic stem cell transplantation (HSCT). The primary
      hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants
      undergoing HSCT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 years of age or older.

          -  Females of childbearing potential must be using an adequate and reliable method of
             contraception (e.g., abstinence, barrier with additional spermicide foam or jelly,
             intrauterine device, hormonal contraception). Males and females must agree to avoid
             conception during treatment and for four weeks following the end of study treatment.

          -  Is undergoing HSCT with planned Fluoroquinolone prophylaxis.

          -  Informed consent is provided.

        Exclusion Criteria:

          -  Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with
             the presence of either toxin A and/or B [or their respective genes, tcdA and/or tcdB]
             of C. difficile in the stool) or current treatment for CDAD.

          -  Undergoing cord blood transplants.

          -  Has fulminant colitis, toxic megacolon, or ileus.

          -  A history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).

          -  Women who are pregnant or are actively breast feeding (all women of childbearing
             potential must have a negative pregnancy test result prior to dosing study drug).

          -  Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin,
             Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide).

          -  Any other condition that, in the opinion of the investigator, would jeopardize the
             safety or rights of the participant in the study, would make it unlikely for the
             participant to complete the study, or would confound the results of the study.

          -  Participation in other clinical research studies utilizing an investigational agent
             within one month prior to screening and during the study treatment period.