Trials Sponsors Conditions Drugs Pricing

Conditions

Clostridium Infections Diarrhea

Keywords

CDAD, Clostridium difficile, diarrheaClostridium difficile-Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

Cure Rate at End of Therapy
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.
Study day 10 (+/- 2 days)

Secondary Outcomes (2)

Recurrence
Study days 11-40
Global Cure
End of Study

Study Arms (2)

1

ACTIVE COMPARATOR

Vancomycin

Drug: Vancomycin

2

EXPERIMENTAL

PAR-101/OPT-80

Drug: PAR-101/OPT-80

Interventions

PAR-101/OPT-80Drug

capsules

VancomycinDrug

Capsules

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Males/females with CDAD
Females must use adequate contraception

Sponsors & Collaborators

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

Study Sites (116)

Gadsden, Alabama, United States

Phoenix, Arizona, United States

Hot Springs, Arkansas, United States

La Mesa, California, United States

Modesto, California, United States

Palm Springs, California, United States

Rancho Mirage, California, United States

Related Publications (5)

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. doi: 10.1016/S1473-3099(11)70374-7. Epub 2012 Feb 8.
PMID: 22321770RESULT
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: 24599770DERIVED

MeSH Terms

Conditions

Clostridium InfectionsDiarrhea

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugates

Results Point of Contact

Title: Chief Scientific Officer
Organization: Optimer Pharmaceuticals, Inc.

Study Officials

Dr. Sherwood Gorbach, MD
Optimer Pharmaceuticals, Inc.
STUDY DIRECTOR

Publication Agreements

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

Enrollment

535 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 3, 2007

Study Start

October 4, 2006

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (116)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (116)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations