Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

NCT00314951 | Completed Phase 3 Results DMC

• 2 other identifiers: 5119-018101.1.C.003
• Study Type: interventional
• Target: 629
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Conditions

Clostridium Infections; Diarrhea

Keywords

CDAD, Clostridium difficile, diarrhea; Clostridium difficile-Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

• Cure Rate at End of Therapy

  Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.

  Study day 10 (+/- 2 days)

Secondary Outcomes (1)

• Recurrence

  Study days 11-40

Other Outcomes (1)

• Global Cure

  End of Study (Day 40)

Study Arms (2)

fidaxomicin

EXPERIMENTAL

Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours \[q12h\] regimen) with intermittent matching placebo to fidaxomicin

Drug: Fidaxomicin; Drug: Matching Placebo to Fidaxomicin

Vancomycin

ACTIVE COMPARATOR

Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \[q6h\] regimen).

Drug: Vancomycin

Interventions

Fidaxomicin DRUG

200 mg oral capsules two times daily (q12h regimen)

Also known as: PAR-101, OPT-80, Dificid®

fidaxomicin

Vancomycin DRUG

125 mg capsules q6hr (4 times a day)

Vancomycin

Matching Placebo to Fidaxomicin DRUG

Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

fidaxomicin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males/females with CDAD
• Females must use adequate contraception
• Signed informed consent

You may not qualify if:

• Life-threatening CDAD
• Toxic megacolon
• Pregnant
• Concurrent use of diarrheal agents
• Participation in other trials

Sponsors & Collaborators

• Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Related Publications (7)

• Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, Gorbach S, Sears P, Shue YK; OPT-80-003 Clinical Study Group. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011 Feb 3;364(5):422-31. doi: 10.1056/NEJMoa0910812.

  PMID: 21288078 RESULT

• D'Agostino RB Sr, Collins SH, Pencina KM, Kean Y, Gorbach S. Risk estimation for recurrent Clostridium difficile infection based on clinical factors. Clin Infect Dis. 2014 May;58(10):1386-93. doi: 10.1093/cid/ciu107. Epub 2014 Mar 5.

  PMID: 24599770 DERIVED

• Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013 Jul 1;31(19):2493-9. doi: 10.1200/JCO.2012.45.5899. Epub 2013 May 28.

  PMID: 23715579 DERIVED

• Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S154-61. doi: 10.1093/cid/cis462.

  PMID: 22752865 DERIVED

• Louie TJ, Cannon K, Byrne B, Emery J, Ward L, Eyben M, Krulicki W. Fidaxomicin preserves the intestinal microbiome during and after treatment of Clostridium difficile infection (CDI) and reduces both toxin reexpression and recurrence of CDI. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S132-42. doi: 10.1093/cid/cis338.

  PMID: 22752862 DERIVED

• Nerandzic MM, Mullane K, Miller MA, Babakhani F, Donskey CJ. Reduced acquisition and overgrowth of vancomycin-resistant enterococci and Candida species in patients treated with fidaxomicin versus vancomycin for Clostridium difficile infection. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S121-6. doi: 10.1093/cid/cis440.

  PMID: 22752860 DERIVED

• Figueroa I, Johnson S, Sambol SP, Goldstein EJ, Citron DM, Gerding DN. Relapse versus reinfection: recurrent Clostridium difficile infection following treatment with fidaxomicin or vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S104-9. doi: 10.1093/cid/cis357.

  PMID: 22752857 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Diarrhea

Interventions

Fidaxomicin; OPT 80; Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: May 2, 2006
• Primary Completion: July 23, 2008
• Study Completion: August 21, 2008
• Last Updated: April 21, 2017
• Results First Posted: October 26, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share