A Phase 3 interventional study of Fidaxomicin and Vancomycin in Clostridium Infections and Diarrhea, sponsored by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-04-21.
Sponsored by Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 3, Interventional, and Treatment
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin 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.
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
This study's enrollment of 629 is above the median of 65 across 233 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \[q6h\] regimen).
Drug: Vancomycin
200 mg oral capsules two times daily (q12h regimen)
Also known as: PAR-101, OPT-80, Dificid®
125 mg capsules q6hr (4 times a day)
Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
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.
Time frame: Study day 10 (+/- 2 days)
Recurrence
Percentage of participants 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.
Time frame: Study days 11-40
Global Cure
Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.
Time frame: End of Study (Day 40)
Subjects were enrolled from May 2006 to August 2008 by centers in the United States and Canada.
| Milestone | Vancomycin | Fidaxomicin |
|---|---|---|
| Started | 323 | 306 |
| Completed | 323 | 300 |
| Not completed | 0 | 6 |
| Milestone | Vancomycin | Fidaxomicin |
|---|---|---|
| Started | 323 | 300 |
| Completed | 307 | 289 |
| Not completed | 16 | 11 |
| Withdrew: Didn't meet criteria for mitt population | 16 | 11 |
| Milestone | Vancomycin | Fidaxomicin |
|---|---|---|
| Started | 307 | 289 |
| Completed | 263 | 255 |
| Not completed | 44 | 34 |
| Withdrew: Mitt failure | 44 | 34 |
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.
| Percentage of Participants | Vancomycin | Fidaxomicin |
|---|---|---|
| Cure Rate at End of Therapy | 85.7 (81.3 to 89.2) | 88.2 (84.0 to 91.5) |
Percentage of participants 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.
| Percentage of Participants | Vancomycin | Fidaxomicin |
|---|---|---|
| Recurrence | 25.1 | 15.7 |
Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.
| Percentage of Participants | Vancomycin | Fidaxomicin |
|---|---|---|
| Global Cure | 64.2 | 74.4 |
Collected over From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vancomycin | — | 78/323 (24.1%) | 195/323 (60.4%) |
| Fidaxomicin | — | 75/300 (25%) | 187/300 (62.3%) |
| Event | Vancomycin | Fidaxomicin |
|---|---|---|
| Clostridium difficile colitisInfections and infestations | 6/323 | 3/300 |
| PneumoniaInfections and infestations | 5/323 | 4/300 |
| AnaemiaBlood and lymphatic system disorders | 1/323 | 4/300 |
| Cardiac failure congestiveCardiac disorders | 2/323 | 4/300 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/323 | 4/300 |
| Renal failure acuteRenal and urinary disorders | 1/323 | 4/300 |
| HypokalaemiaMetabolism and nutrition disorders | 4/323 | 0/300 |
| Atrial fibrillationCardiac disorders | 1/323 | 3/300 |
| SepsisInfections and infestations | 3/323 | 3/300 |
| Blood uric acid increasedInvestigations | 1/323 | 3/300 |
| Event | Vancomycin | Fidaxomicin |
|---|---|---|
| NauseaGastrointestinal disorders | 28/323 | 31/300 |
| HypokalaemiaMetabolism and nutrition disorders | 24/323 | 22/300 |
| HeadacheNervous system disorders | 14/323 | 20/300 |
| VomitingGastrointestinal disorders | 14/323 | 18/300 |
| PyrexiaGeneral disorders | 16/323 | 16/300 |
| Oedema peripheralGeneral disorders | 17/323 | 13/300 |
| Urinary tract infectionInfections and infestations | 12/323 | 12/300 |
| DizzinessNervous system disorders | 4/323 | 12/300 |
| DiarrhoeaGastrointestinal disorders | 12/323 | 9/300 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/323 | 11/300 |
| Age, Continuous(years) | Vancomycin | Fidaxomicin | Total |
|---|---|---|---|
| Mean | 62.9 ± 16.9 | 60.3 ± 16.9 | 61.6 ± 16.9 |
| Sex: Female, Male(Participants) | Vancomycin | Fidaxomicin | Total |
|---|---|---|---|
| Female | 169 | 164 | 333 |
| Male | 138 | 125 | 263 |
| Region of Enrollment(participants) | Vancomycin | Fidaxomicin | Total |
|---|---|---|---|
| United States | 186 | 165 | 351 |
| Canada | 121 | 124 | 245 |
No study locations are listed for this record.
Plan to share: 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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Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)