Trial · NCT01983683
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
NCT01983683, Phase 3, Completed, Actelion; results first posted 2018-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea. Trials, record NCT01983683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01983683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
- NCT number
- NCT01983683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 631 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Clostridium Difficile Infection
- Interventions
- Cadazolid, Vancomycin, Cadazolid-matching placebo, Vancomycin-matching placebo
- First posted
- 2013-11-14
- Last updated
- 2025-02-04
- Results first posted
- 2018-04-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population | Up to Day 12 on average (end-of-treatment + 2 days) | Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive). CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below. |
| Primary | Clinical Cure Rate (CCR) in the Per-protocol Population | Up to Day 12 on average (end-of-treatment + 2 days) | Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below. |
| Secondary | Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population | Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days) | Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT). |
| Secondary | Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) | Up to Day 10 | Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment. The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point. |
| Secondary | Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores | Baseline to End of Treatment (10 days after starting study drug) + 2 days | CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms. |
| Other | Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population | Up to Day 12 on average (up to end-of-treatment + 2 to 4 days) | ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below. |
| Other | Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population | Up to Day 12 on average (up to end-of-treatment + 2 to 4 days) | ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below. |
| Other | Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5 | Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days) | ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having 'Not Sustained Cure' for the analysis. ISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT). |
| Other | Sustained Cure Rate (SCR) in the Per-protocol Population | Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days) | Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity. |
| Other | Recurrence Rate | Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days) | Recurrence is defined as the occurrence of a new episode of diarrhea (\> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population | Up to Day 12 on average (end-of-treatment + 2 days) | Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues. | Percentage of participants | NUMBER |
| PRIMARY | Clinical Cure Rate (CCR) in the Per-protocol Population | Up to Day 12 on average (end-of-treatment + 2 days) | per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable. | Percentage of participants | NUMBER |
| SECONDARY | Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population | Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days) | Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues. | Percentage of subjects | NUMBER |
| SECONDARY | Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) | Up to Day 10 | Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues. | KM estimate (% subjects with ROD) | NUMBER |
| SECONDARY | Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores | Baseline to End of Treatment (10 days after starting study drug) + 2 days | All subjects from the modified intent-to-treat population, excluding those who participated in the validation sub-study. No imputation of missing scores is performed prior to deriving response status. Subjects with missing values at baseline or at Day 3 are considered to be non-responders. | Scores on a scale | NUMBER |
| OTHER_PRE_SPECIFIED | Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population | Up to Day 12 on average (up to end-of-treatment + 2 to 4 days) | Modified intent-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population | Up to Day 12 on average (up to end-of-treatment + 2 to 4 days) | Per-protocol population: all subjects from the mITT analysis set without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5 | Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days) | Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Sustained Cure Rate (SCR) in the Per-protocol Population | Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days) | Per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Recurrence Rate | Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days) | Subjects from the modified intent-to-treat analysis set (mITT) with clinical cure | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population | Cadazolid | 81 | 95% Confidence Interval 76.1 to 85.1 | Percentage of participants | |
| Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population | Vancomycin | 85.7 | 95% Confidence Interval 81.3 to 89.2 | Percentage of participants | |
| Clinical Cure Rate (CCR) in the Per-protocol Population | Cadazolid | 86.6 | 95% Confidence Interval 81.8 to 90.3 | Percentage of participants | |
| Clinical Cure Rate (CCR) in the Per-protocol Population | Vancomycin | 91.5 | 95% Confidence Interval 87.5 to 94.3 | Percentage of participants | |
| Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population | Cadazolid | 63.4 | 95% Confidence Interval 57.8 to 68.8 | Percentage of subjects | |
| Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population | Vancomycin | 61.8 | 95% Confidence Interval 56.2 to 67.1 | Percentage of subjects | |
| Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) | Cadazolid | Day 1 | 51.0 | 95% Confidence Interval 45.4 to 56.9 | KM estimate (% subjects with ROD) |
| Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) | Vancomycin | Day 1 | 45.8 | 95% Confidence Interval 40.4 to 51.6 | KM estimate (% subjects with ROD) |
| Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) | Cadazolid | Day 2 | 64.5 | 95% Confidence Interval 59.0 to 70.0 | KM estimate (% subjects with ROD) |
| Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) | Vancomycin | Day 2 | 59.8 | 95% Confidence Interval 54.3 to 65.4 | KM estimate (% subjects with ROD) |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cadazolid | 298 | |
| Overall Study | STARTED | Vancomycin | 311 | |
| Overall Study | COMPLETED | Cadazolid | 260 | |
| Overall Study | COMPLETED | Vancomycin | 260 | |
| Overall Study | NOT COMPLETED | Cadazolid | 38 | |
| Overall Study | NOT COMPLETED | Vancomycin | 51 |
Source ClinicalTrials.gov
Adverse events174
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 | Clostridium difficile infection | Infections and infestations | Cadazolid | 10 | 294 | 11 |
| other | Clostridium difficile infection | Infections and infestations | Vancomycin | 17 | 307 | 17 |
| other | Headache | Nervous system disorders | Cadazolid | 13 | 294 | 15 |
| other | Headache | Nervous system disorders | Vancomycin | 18 | 307 | 21 |
| other | Nausea | Gastrointestinal disorders | Cadazolid | 16 | 294 | 19 |
| other | Nausea | Gastrointestinal disorders | Vancomycin | 11 | 307 | 13 |
| other | Pyrexia | General disorders | Cadazolid | 15 | 294 | 20 |
| other | Pyrexia | General disorders | Vancomycin | 11 | 307 | 12 |
| serious | Abdominal distension | Gastrointestinal disorders | Cadazolid | 1 | 294 | 1 |
| serious | Abdominal distension | Gastrointestinal disorders | Vancomycin | 0 | 307 | 0 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cadazolid | 11 | 294 |
| Total, all-cause mortality | Vancomycin | 15 | 307 |
| Total, other adverse events | Cadazolid | 47 | 294 |
| Total, other adverse events | Vancomycin | 51 | 307 |
| Total, serious adverse events | Cadazolid | 35 | 294 |
| Total, serious adverse events | Vancomycin | 46 | 307 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cadazolid vs Vancomycin: deaths from any cause | Trial comparisons |
| Cadazolid vs Vancomycin: serious adverse events | Trial comparisons |
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.
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