Trial · NCT01424670
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
NCT01424670, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2019-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis. Trials, record NCT01424670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01424670
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
- NCT number
- NCT01424670
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 511 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Multidrug-resistant Tuberculosis
- Interventions
- Delamanid + OBR, Placebo + OBR
- First posted
- 2011-08-29
- Last updated
- 2019-05-15
- Results first posted
- 2019-05-15
- Limitations and caveats
The primary endpoint was established at 6 months. Treatment, intensive data collection, and statistical power calculations focused on the first 6 months. Given the unexpected placebo + OBR response, cautiously interpret 18, 24, and 30 month outcomes.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System | Month 6 | SCC at 6 months was determined by the observation of a sputum specimen negative for growth of mycobacterium tuberculosis (MTB) using the MGIT culture system, followed by at least 1 confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive (defined as at least 2 observed positive results, not taking into account indeterminate, missing, or contaminated results). 2 specimens were collected at each visit and an algorithm in the statistical analysis plan (SAP) was used to define a single representative result. Time to SCC was then defined as the interval between the date of first dose of IMP and the date of first of 2 consecutive negative single representative time points that were at least 25 days apart. The median time in days to SCC up to Month 6 is presented. |
| Secondary | Proportion of Participants With SCC At 2 And 6 Months Using MGIT | Month 2 and Month 6 | SCC was evaluated at 2 and 6 months (6-month Intensive Period) using MGIT. SCC at 2 months was defined to occur at the date of collection of the first sputum specimen with mycobacterial culture negative for growth of MTB using MGIT culture, followed by at least 1 confirmatory negative MGIT culture result at least 25 days after the first negative specimen and not followed by any sputum specimens positive for growth in the MGIT culture at any point up to 3 months (Week 12). SCC at 6 months was determined by the observation of a sputum specimen negative for growth of MTB using the MGIT culture system, followed by at least 1 confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive (defined as at least 2 observed positive results, not taking into account indeterminate, missing, or contaminated results). 2 specimens were collected at each visit and an algorithm in the SAP was used to define a single representative result. |
| Secondary | Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT | Month 18, Month 24, and Month 30 | Sustained SCC was defined as SCC achieved by Month 6 and not followed by a confirmed positive thereafter, where confirmed positive was defined as 2 or more observed positive single representative culture results, not taking into account indeterminate, missing, or contaminated results. Sustained SCC was analyzed at Month 18 to 30 using MGIT. |
| Secondary | Treatment Outcomes Assessed By Principal Investigators (PI)At The End Of Treatment With OBR | Month 24 | Final treatment outcomes were assessed by the Principal Investigator (PI) at the end of treatment with OBR (24 months post randomization) according to the 2008 World Health Organization (WHO) outcome definitions for treating participants with multidrug-resistant tuberculosis (MDR TB). Frequency counts and percentage of participants achieving favorable and unfavorable outcomes were provided by treatment group. Participants who had non-missing Principal Investigator assessed treatment outcomes at the end of treatment with OBR were included in the analysis. |
| Secondary | Number of Participants Who Developed Resistance To Delamanid | Up to Month 30 | Acquired resistance was defined as a post-baseline resistant result at any time point after a Baseline susceptible result. The overall resistance to delamanid during the trial was assessed. |
| Secondary | Mean (Time Averaged) Area Under The Curve (AUC) Of Change From Baseline In Time To Detection (TTD) To Month 6 Using MGIT | Baseline, up to Month 6 | The value for TTD was defined (in days) as the time interval from inoculation until a MGIT machine detects a positive signal for a sputum culture. The AUC of the change from Baseline for TTD in days (from Baseline to Month 6) summarizes the overall participant response for the treatment period. The change from Baseline in original time to detection of MGIT positive signal, in days, up to 6 months was performed using AUC in MGIT. The Baseline was defined as the average of Day -1 and Day 1 values if cultures on both days were positive; if only 1 culture was positive, the value for TTD for the positive culture was used as the Baseline. The TTD is Time to Detection measured by day, so the unit of AUC of change from baseline in TTD is day\*day. Since "Mean AUC" is reported, which is actually "Time Averaged AUC," the AUC was divided by the duration of the observation, and thus the unit of the Mean AUC is day. |
| Secondary | Mean Change From Baseline In TTD Using The MGIT System | Baseline, Week 1, Week 2, Week 3, Week 24, Week 26, and Last visit (Month 18 or last visit for participants treated beyond Month 18) | The value for TTD was defined (in days) as the time interval from inoculation until a MGIT machine detects a positive signal for a sputum culture during the routine 42-day incubation period. TTD analysis was based only on the corresponding qualitative sputum results of pure positive and pure negative cultures in days and hours of the initial positive signal for a culture from the MGIT printout. Mean change is reported for Baseline, Week 1, Week 2, Week 3, Week 24, Week 26, and Last visit (Month 18 or last visit for participants treated beyond Month 18). |
| Secondary | Proportion of Participants With Final Outcome At Month 30 As A Treatment Success Or Failure (Including Relapse) Using MGIT | Month 30 | Treatment success was defined as achieving SCC by 6 months using MGIT, completing the trial out to 30 months with sustained SCC and alive at the last contact for follow-up. All other participants were treatment failures who failed to achieve SCC by Month 6, achieved SCC but have a confirmed positive, early terminate from the trial prior to the Month 30 visit but are alive at the last contact for follow-up, lost to follow-up and vital status unknown and death. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System | Month 6 | The modified intent-to-treat (MITT) sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both. | Days | MEDIAN |
| SECONDARY | Proportion of Participants With SCC At 2 And 6 Months Using MGIT | Month 2 and Month 6 | The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT | Month 18, Month 24, and Month 30 | The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Outcomes Assessed By Principal Investigators (PI)At The End Of Treatment With OBR | Month 24 | The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Developed Resistance To Delamanid | Up to Month 30 | The intent-to-treat (ITT) sample comprised all randomized participants. | participants | NUMBER |
| SECONDARY | Mean (Time Averaged) Area Under The Curve (AUC) Of Change From Baseline In Time To Detection (TTD) To Month 6 Using MGIT | Baseline, up to Month 6 | The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both, who had both a baseline and at least one post baseline TTD value. | days | MEAN |
| SECONDARY | Mean Change From Baseline In TTD Using The MGIT System | Baseline, Week 1, Week 2, Week 3, Week 24, Week 26, and Last visit (Month 18 or last visit for participants treated beyond Month 18) | The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both. | days | MEAN |
| SECONDARY | Proportion of Participants With Final Outcome At Month 30 As A Treatment Success Or Failure (Including Relapse) Using MGIT | Month 30 | The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System | Delamanid + OBR | 51 | 95% Confidence Interval 43 to 57 | Days | |
| Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System | Placebo + OBR | 57 | 95% Confidence Interval 56 to 64 | Days | |
| Proportion of Participants With SCC At 2 And 6 Months Using MGIT | Delamanid + OBR | At Month 2 | 132 | Participants | |
| Proportion of Participants With SCC At 2 And 6 Months Using MGIT | Placebo + OBR | At Month 2 | 54 | Participants | |
| Proportion of Participants With SCC At 2 And 6 Months Using MGIT | Delamanid + OBR | At Month 6 | 198 | Participants | |
| Proportion of Participants With SCC At 2 And 6 Months Using MGIT | Placebo + OBR | At Month 6 | 87 | Participants | |
| Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT | Delamanid + OBR | At 18 months | 180 | Participants | |
| Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT | Placebo + OBR | At 18 months | 83 | Participants | |
| Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT | Delamanid + OBR | At 24 months | 178 | Participants | |
| Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT | Placebo + OBR | At 24 months | 82 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 6-Month Intensive Period (182 Days) | STARTED | Delamanid + OBR | 341 | |
| 6-Month Intensive Period (182 Days) | STARTED | Placebo + OBR | 170 | |
| 6-Month Intensive Period (182 Days) | Received at Least 1 Dose of Study Drug | Delamanid + OBR | 341 | |
| 6-Month Intensive Period (182 Days) | Received at Least 1 Dose of Study Drug | Placebo + OBR | 170 | |
| 6-Month Intensive Period (182 Days) | COMPLETED | Delamanid + OBR | 322 | |
| 6-Month Intensive Period (182 Days) | COMPLETED | Placebo + OBR | 156 | |
| 6-Month Intensive Period (182 Days) | NOT COMPLETED | Delamanid + OBR | 19 | |
| 6-Month Intensive Period (182 Days) | NOT COMPLETED | Placebo + OBR | 14 | |
| Continuation Period | STARTED | Delamanid + OBR | 322 | |
| Continuation Period | STARTED | Placebo + OBR | 156 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events380
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 | Anaemia | Blood and lymphatic system disorders | Delamanid + OBR | 17 | 341 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + OBR | 9 | 170 | |
| other | Palpitations | Cardiac disorders | Delamanid + OBR | 19 | 341 | |
| other | Palpitations | Cardiac disorders | Placebo + OBR | 12 | 170 | |
| other | Deafness bilateral | Ear and labyrinth disorders | Delamanid + OBR | 15 | 341 | |
| other | Deafness bilateral | Ear and labyrinth disorders | Placebo + OBR | 9 | 170 | |
| other | Hypoacusis | Ear and labyrinth disorders | Delamanid + OBR | 15 | 341 | |
| other | Hypoacusis | Ear and labyrinth disorders | Placebo + OBR | 15 | 170 | |
| other | Tinnitus | Ear and labyrinth disorders | Delamanid + OBR | 71 | 341 | |
| other | Tinnitus | Ear and labyrinth disorders | Placebo + OBR | 36 | 170 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delamanid + OBR | 18 | 341 |
| Total, all-cause mortality | Placebo + OBR | 8 | 170 |
| Total, other adverse events | Delamanid + OBR | 335 | 341 |
| Total, other adverse events | Placebo + OBR | 165 | 170 |
| Total, serious adverse events | Delamanid + OBR | 89 | 341 |
| Total, serious adverse events | Placebo + OBR | 47 | 170 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30630778 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Delamanid + OBR vs Placebo + OBR: Number of Participants Who Developed Resistance To Delamanid | Trial comparisons |
| Delamanid + OBR vs Placebo + OBR: deaths from any cause | Trial comparisons |
| Delamanid + OBR vs Placebo + OBR: 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.
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/NCT01424670
GET https://conductscience.org/api/trials/v1/NCT01424670/results?page=2