Clostridium InfectionsPhase 3NCT00468728
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
A Phase 3 study testing PAR-101/OPT-80 and Vancomycin in people with Clostridium Infections and Diarrhea, run by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 116 sites in 9 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Clostridium Infections, Diarrhea
- What is being tested?
- PAR-101/OPT-80 and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 116 sitesin 9 countries
- Study dates
- 4 Oct 2006to 11 Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Who cannot join
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
Trial locations and contacts
116 sites in 9 countries.
116 sites in 9 countries
United States53 sites
Study site
Akron, Ohio
Study site
Amherst, Ohio
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Bowling Green, Kentucky
Study site
Butte, Montana
Study site
Cedar Knolls, New Jersey
Study site
Charleston, South Carolina
Study site
Charleston, West Virginia
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbia, Missouri
Study site
Columbus, Ohio
Study site
Dayton, Ohio
Study site
Detroit, Michigan
Study site
Fargo, North Dakota
Study site
Gadsden, Alabama
Study site
Hot Springs, Arkansas
Study site
Idaho Falls, Idaho
Study site
Indianapolis, Indiana
Study site
Jena, Louisiana
Study site
Keego Harbor, Michigan
Study site
La Mesa, California
Study site
Marietta, Georgia
Study site
Maywood, Illinois
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
Modesto, California
Study site
Neptune City, New Jersey
Study site
New Orleans, Louisiana
Study site
Palm Springs, California
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Port Orange, Florida
Study site
Rancho Mirage, California
Study site
Rapid City, South Dakota
Study site
Royal Oak, Michigan
Study site
San Antonio, Texas
Study site
San Jose, California
Study site
Santa Ana, California
Study site
Sarasota, Florida
Study site
Savannah, Georgia
Study site
Seattle, Washington
Study site
Sioux Falls, South Dakota
Study site
The Bronx, New York
Study site
Tupelo, Mississippi
Study site
Vallejo, California
Study site
Washington D.C., District of Columbia
Study site
West Roxbury, Massachusetts
Study site
Winchester, Virginia
Study site
Winston-Salem, North Carolina
United Kingdom13 sites
Study site
Barnsley
Study site
Brighton
Study site
Cambridge
Study site
Derriford, Plymouth
Study site
Edinburgh
Study site
Great Yarmouth, Norfolk
Study site
Liege
Study site
London
Study site
Nottingham
Study site
Oxford
Study site
Oxon
Study site
Surrey
Study site
York
Belgium11 sites
Study site
Aalst
Study site
Alast
Study site
Antwerp
Study site
Brussels
Study site
Columbia
Study site
Ghent
Study site
Kortrijk
Study site
Liège
Study site
Mons
Study site
Montigny-le-Tilleul
Study site
Wilrijk
Canada9 sites
Study site
Calgary, Alberta
Study site
Chicoutimi, Quebec
Study site
Edmonton, Alberta
Study site
Hamilton, Ontario
Study site
Montreal, Quebec
Study site
Saint-Jérôme, Quebec
Study site
Sherbrooke, Quebec
Study site
Toronto, Ontario
Study site
Trois-Rivières, Quebec
France9 sites
Study site
Amiens
Study site
Caen
Study site
Clichy
Study site
Garches
Study site
Grenoble
Study site
Lille
Study site
Tourcoing
Study site
Tours
Study site
Valenciennes
Germany8 sites
Study site
Cologne
Study site
Düsseldorf
Study site
Frankfurt
Study site
Hanover
Study site
Hofheim am Taunus
Study site
Lübeck
Study site
Magdeburg
Study site
Regensburg
Italy5 sites
Study site
Busto Arsizio
Study site
Genova
Study site
Milan
Study site
Modena
Study site
Torino
Spain5 sites
Study site
Badalona
Study site
Barcelona
Study site
Madrid
Study site
Palma de Mallorca
Study site
Seville
About this study
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)
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).
Read the 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.
- Conditions
- Clostridium Infections, Diarrhea
- Being tested
- PAR-101/OPT-80, Vancomycin
- Keywords
- CDAD, Clostridium difficile, diarrhea, Clostridium difficile-Associated Diarrhea
- Medical subject headings
- Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAR-101/OPT-80Drug
capsules
VancomycinDrug
Capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Vancomycin Receives: Drug: Vancomycin |
| 2 | Experimental | PAR-101/OPT-80 Receives: Drug: PAR-101/OPT-80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study day 10 (+/- 2 days)
Secondary outcomes (2)
Recurrence
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.
Measured: Study days 11-40
Global Cure
Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study start4 Oct 2006
- Primary completion11 Dec 2009
- Study completion11 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clostridium InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Sherwood Gorbach, MD, Study director, Optimer Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468728
- Sponsor's protocol ID
- 5119-019
- Other IDs
- 101.1.C.004
- Status last verified
- Mar 2017
- First submitted
- 1 May 2007
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
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.
PubMed 22321770D'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.
PubMed 24599770Cornely 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.
PubMed 23715579Cornely 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.
PubMed 22752865Figueroa 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.
PubMed 22752857
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00468728
- Acronym / sponsor ID
- 5119-019
- Conditions
- Clostridium Infections, Diarrhea
- Keywords
- CDAD, Clostridium difficile, diarrhea, Clostridium difficile-Associated Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2006 (actual)
- Primary completion
- 11 Dec 2009 (actual)
- Study completion
- 11 Dec 2009 (actual)
- First posted
- 3 May 2007 (estimated)
- Results
- Posted 29 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: VancomycinVancomycin |
| 2 | Experimental | Drug: PAR-101/OPT-80PAR-101/OPT-80 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Key exclusion criteria (5 listed)
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAR-101/OPT-80capsules | Drug | 2 |
| VancomycinCapsules | Drug | 1 |
Primary outcome
Cure Rate at End of Therapy
Time frame: Study day 10 (+/- 2 days)
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.
2 secondary outcomes
Recurrence
Time frame: Study days 11-40
Global Cure
Time frame: End of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22321770Cornely 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.
- Derived from this study: PubMed 24599770D'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.
- Derived from this study: PubMed 23715579Cornely 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.
- Derived from this study: PubMed 22752865Cornely 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.
- Derived from this study: PubMed 22752857Figueroa 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.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sherwood Gorbach, MD study director
Optimer Pharmaceuticals, Inc.
116 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PAR-101/OPT-80 and Vancomycin in people with Clostridium Infections and Diarrhea, run by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 116 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in United States, United Kingdom, Belgium, Canada, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate at End of Therapy (time frame: Study day 10 (+/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468728, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.