# Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)

> **NCT01691248** · PHASE3 · COMPLETED · sponsor: **Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)** · enrollment: 611 (actual)

## Conditions studied

- Clostridium Difficile-Associated Diarrhea (CDAD)

## Interventions

- **DRUG:** fidaxomicin
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01691248
- **Lead sponsor:** Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-10-10
- **Primary completion:** 2015-03-18
- **Final completion:** 2015-04-16
- **Target enrollment:** 611 (ACTUAL)
- **Last updated:** 2018-09-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01691248

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01691248, "Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT01691248. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*