At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 611 enrolled

Drug / intervention

fidaxomicin +1 moredrug

Likely dose

Fidaxomicin 200 mg orally once daily from start of conditioning (±2 days) prior to transplantation or at time of fluoroquinolone initiation, continuing 7 days after neutrophil engraftment or completion of fluoroquinolone regimen (whichever later)AI-extracted

Key inclusion· 3

✓Age 18 years or older
✓Undergoing hematopoietic stem cell transplantation with planned fluoroquinolone prophylaxis
✓Willing and able to provide informed consent

Key exclusion· 7

✕Active C. difficile-associated diarrhea infection (evidenced by diarrhea plus toxin A/B or genes tcdA/tcdB in stool) or current CDAD treatment
✕Undergoing cord blood transplantation
✕Fulminant colitis, toxic megacolon, or ileus
✕History of inflammatory bowel disease (ulcerative colitis or Crohn's disease)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01691248

NCT01691248Phase 3Completed

Compare CT.gov

DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Sep 24, 2012·Updated Sep 18, 2018

In Brief

A Phase 3 clinical trial evaluating fidaxomicin and Placebo for Clostridium Difficile-Associated Diarrhea (CDAD). Completed, enrolled 611 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsClostridium Difficile-Associated Diarrhea (CDAD)

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedSep 2012

Enrollment StartOct 2012

Primary CompletionMar 2015

Study CompletionApr 2015

TodayJul 2026

First PostedSep 24, 2012

Enrollment StartOct 10, 2012

Primary CompletionMar 18, 2015

Study CompletionApr 16, 2015

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 13.8 years ago

Interventions

fidaxomicindrug

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.

Placebodrug

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.