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Complete title: 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
|Research Study Number||2634.00|
|Principal Investigator||Steven Pergam, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Male or female 18 years of age or older.
- Female subjects 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). Subjects (both male and female) must agree to avoid conception during treatment and for four weeks following the end of study treatment.
- Individuals undergoing HSCT with fluoroquinolone prophylaxis.
- Informed consent is provided.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Undergoing cord blood transplants.
- Subject 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 subject participating in the study, would make it unlikely for the subject 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.
Other exclusion criteria may apply.
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