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

This study has been completed.

Sponsor:

Information provided by:

Optimer Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00468728

First received: May 1, 2007

Last updated: August 8, 2011

Last verified: August 2011

History of Changes

Results First Received: July 1, 2011

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
Conditions:	Clostridium Infections Diarrhea
Interventions:	Drug: PAR-101/OPT-80 Drug: Vancomycin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from April 2007 to November 2009 by centers in the United States, Canada, France, Spain, Belgium, Germany, United Kingdom, Italy, and Sweden.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Vancomycin	125 mg administered 4 times daily (q6hr)
PAR-101/OPT-80	200 mg administered twice daily (q12hr)

Participant Flow for 3 periods

Period 1: Enrollment

	Vancomycin	PAR-101/OPT-80
STARTED	264	271
COMPLETED	260 ^[1]	264 ^[1]
NOT COMPLETED	4	7

[1]	1 fidaxomicin subject received vancomycin, 11 subjects didn't take drug

Period 2: Treatment

	Vancomycin	PAR-101/OPT-80
STARTED	260	264
COMPLETED	256	253
NOT COMPLETED	4	11
criteria for mITT population	4	11

Period 3: Follow-up

	Vancomycin	PAR-101/OPT-80
STARTED	256	253
COMPLETED	222	222
NOT COMPLETED	34	31
mITT failure	34	31

Baseline Characteristics

Show Baseline Characteristics

Outcome Measures

Show All Outcome Measures

1. Primary:

Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ]

Show Outcome Measure 1

2. Secondary:

Recurrence [ Time Frame: Study days 11-40 ]

Show Outcome Measure 2

3. Secondary:

Global Cure [ Time Frame: End of Study ]

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chief Scientific Officer
Organization: Optimer Pharmaceuticals, Inc.
phone: 1-855-343-4243
e-mail: medinfo@optimerpharma.com

No publications provided by Optimer Pharmaceuticals

Publications automatically indexed to this study:

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

To Top