Trial · NCT02395848
Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
NCT02395848, Phase 3, Terminated, McMaster University; results first posted 2023-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection. Trials, record NCT02395848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02395848
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
- NCT number
- NCT02395848
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- McMaster University
- Conditions
- Clostridium Difficile Infection
- Interventions
- Fidaxomicin
- First posted
- 2015-03-24
- Last updated
- 2023-03-24
- Results first posted
- 2023-03-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response at 30-day Completion of Fidaxomicin | 30 days | clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well through study day 30. |
| Primary | Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin | 8 week following completion of fidaxomicin | sustained clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well 8 weeks following completion of fidaxomicin |
| Primary | Treatment Failure | Up to 8 weeks following completion of fidaxomicin | patients not meeting the definition of cure and requiring additional antibiotics for current CDI episode |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response at 30-day Completion of Fidaxomicin | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin | 8 week following completion of fidaxomicin | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Treatment Failure | Up to 8 weeks following completion of fidaxomicin | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response at 30-day Completion of Fidaxomicin | Fidaxomicin | 24 | Participants | ||
| Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin | Fidaxomicin | 22 | Participants | ||
| Treatment Failure | Treatment Failure Requiring Additional Treatment for Recurrent C Difficile Infection | 7 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fidaxomicin | 31 | |
| Overall Study | COMPLETED | Fidaxomicin | 29 | |
| Overall Study | NOT COMPLETED | Fidaxomicin | 2 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Fidaxomicin | 7 | 29 | 7 |
| serious | Clostridium difficile infection | Gastrointestinal disorders | Fidaxomicin | 1 | 29 | 1 |
| serious | Electrolyte disorder and uremia in a patient with pre-existing renal failure on chronic hemodialysis | Renal and urinary disorders | Fidaxomicin | 1 | 29 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fidaxomicin | 0 | 29 |
| Total, other adverse events | Fidaxomicin | 7 | 29 |
| Total, serious adverse events | Fidaxomicin | 2 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02395848
GET https://conductscience.org/api/trials/v1/NCT02395848/registered