Are you scheduled for a stem cell transplant?


16535

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 PROTOCOL OPT-80-302

Medicine

Beitinjaneh Amer, M

UVa Health System seeks adults undergoing a stem cell transplant for a research study. The purpose of the study is to see if an investigational drug is safe and effective for preventing Clostridium difficil Associated Diarrhea (CDAD). CDAD is a potentially serious form of diarrhea which is more common in those who undergo stem cell transplant. The study involves taking study drug or placebo once daily for at least three weeks. There will be up to 6 study visits over a 2-4 month period of time. Each visit will last about 3-8 hours. Most study visits will occur while you are an inpatient in the hospital or in conjunction with outpatient appointments that are scheduled for your regular cancer care. Visits will include blood draws, stool samples, and evaluation of signs and symptoms of CDAD. Study-related blood tests, stool sample tests, and the study drug will be provided free of charge. No compensation is provided for being in this study. For more information please contact: Hannah Spencer, MSc Clinical Research Coordinator (434) 243-5811 Email: hes3x@hscmail.mcc.virginia.edu IRB-HSR # 16535

Hematology/Oncology

Adult

Stem Cell Transplant

Cancer (Oncology)

Ill

No Compensation

Hannah Spencer

hes3x@virginia.edu

4342435811