PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) - Full Text View

Purpose

This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Condition	Intervention	Phase
Clostridium Infections Diarrhea	Drug: PAR-101/OPT-80 Drug: Vancomycin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Vancomycin Vancomycin hydrochloride Fidaxomicin

U.S. FDA Resources

Further study details as provided by Optimer Pharmaceuticals:

Primary Outcome Measures:

Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ] [ Designated as safety issue: No ]
Percentage of subjects 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.

Secondary Outcome Measures:

Recurrence [ Time Frame: Study days 11-40 ] [ Designated as safety issue: No ]
Percentage of subjects with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.
Global Cure [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.

Enrollment:	535
Study Start Date:	April 2007
Study Completion Date:	December 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Vancomycin	Drug: Vancomycin Capsules
Experimental: 2 PAR-101/OPT-80	Drug: PAR-101/OPT-80 capsules

Detailed Description:

The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468728

Show 117 Study Locations

Sponsors and Collaborators

Optimer Pharmaceuticals

Investigators

Study Director:

Dr. Sherwood Gorbach, MD

Optimer Pharmaceuticals, Inc.

More Information

No publications provided by Optimer Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:S154-61.

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:S104-9.

Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, Gorbach S; OPT-80-004 Clinical Study Group. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012 Apr;12(4):281-9. Epub 2012 Feb 8.

Responsible Party:	Y.K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00468728 History of Changes
Obsolete Identifiers:	NCT00427869
Other Study ID Numbers:	101.1.C.004, 101.1.C.004
Study First Received:	May 1, 2007
Results First Received:	July 1, 2011
Last Updated:	August 8, 2011
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Ministry of Health and Consumption Belgium: Federal Agency for Medicinal Products and Health Products Italy: The Italian Medicines Agency Sweden: Medical Products Agency Germany: BfArM

Keywords provided by Optimer Pharmaceuticals:

CDAD, Clostridium difficile, diarrhea
Clostridium difficile-Associated Diarrhea

Additional relevant MeSH terms:

Clostridium Infections
Diarrhea
Gram-Positive Bacterial Infections
Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms

Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013