Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) (DEFLECT-1)

O

Optimer Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Clostridium Difficile-Associated Diarrhea (CDAD)

Treatments

Drug: Placebo
Drug: fidaxomicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01691248
5119-001
OPT-80-302 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

611 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female 18 years of age or older.
  • Females 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). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.
  • Is undergoing HSCT with planned Fluoroquinolone prophylaxis.
  • Informed consent is provided.

Exclusion criteria

  • Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin A and/or B [or their respective genes, tcdA and/or tcdB] of C. difficile in the stool) or current treatment for CDAD.
  • Undergoing cord blood transplants.
  • 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 participant in the study, would make it unlikely for the participant 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

611 participants in 2 patient groups, including a placebo group

Fidaxomicin
Active Comparator group
Description:
200 mg Fidaxomicin tablet once daily for no longer than 40 days
Treatment:
Drug: fidaxomicin
Placebo
Placebo Comparator group
Description:
Placebo tablet once daily for no longer than 40 days
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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