Conditions: Clostridium Difficile-Associated Diarrhea (CDAD)
Keywords: Clostridium difficile Clostridium difficile-Associated Diarrhea Prophylaxis Hematopoietic Stem Cell Transplantation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 611
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 200 mg Fidaxomicin tablet once daily for no longer than 40 days arm 2: Placebo tablet once daily for no longer than 40 days

Interventions: intervention 1: fidaxomicin intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: