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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01691248
Other study ID # 5119-001
Secondary ID OPT-80-302
Status Completed
Phase Phase 3
First received
Last updated
Start date October 10, 2012
Est. completion date April 16, 2015

Study information

Verified date August 2018
Source Optimer Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 611
Est. completion date April 16, 2015
Est. primary completion date March 18, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Clostridium Difficile-Associated Diarrhea (CDAD)
  • Diarrhea

Intervention

Drug:
fidaxomicin
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.
Placebo
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Optimer Pharmaceuticals LLC

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up. CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. Up to 30 days post-treatment
Secondary Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment. CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. Up to 60 days post-treatment
Secondary Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study. CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented. Up to Day 70 of study
See also
  Status Clinical Trial Phase
Terminated NCT00177970 - IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff Phase 4
Completed NCT02218372 - A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) Phase 3