Trial · NCT02619994
Treatment Shortening of MDR-TB Using Existing and New Drugs
NCT02619994, Phase 2, Completed, Seoul National University Hospital; results first posted 2025-01-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment Shortening of MDR-TB Using Existing and New Drugs. Trials, record NCT02619994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02619994
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Shortening of MDR-TB Using Existing and New Drugs
- NCT number
- NCT02619994
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 214 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Tuberculosis, Multidrug-Resistant
- Interventions
- Linezolid, Delamanid, Levofloxacin, Pyrazinamide, Locally-used WHO-approved MDR-TB regimen in Korea
- First posted
- 2015-12-02
- Last updated
- 2025-01-03
- Results first posted
- 2025-01-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success Rate | 24 months after treatment start | To test for non-inferiority of the investigational arm, when the lower limit of the one-sided 97.5% confidence interval of the difference (PT - PC) between investigational and control arms is larger than the non-inferiority margin of - 10%, it will be concluded that the treatment success rate of the investigational arm shows non-inferiority to the treatment success rate of the control arm. (primary consideration for the modified intention-to-treat results) |
| Secondary | Time to Sputum Culture Conversion After Treatment Start | through study completion (24 months after treatment start) | To determine whether time to sputum culture conversion after treatment start is statistically different between the control and investigational arms, the median time will be estimated in each group using the Kaplan-Meier method, and the difference in the distribution of time to culture conversion of the two arms will be compared using the log-rank test. |
| Secondary | Sputum Culture Conversion Proportion | At 2 months of treatment | Culture conversion rate at month 2 of treatment in participants with positive baseline sputum culture (liquid media). |
| Secondary | Treatment Success at the End of Treatment | At the end of treatment | Treatment success rate at the end of treatment. * control arm (20-24 months) * experimental arm (40 or 52 weeks) |
| Secondary | Proportion of Reverting to Positive Sputum Culture After the End of Treatment | At 24months after treatment start | The proportion of patients who experienced a reversion between the end of treatment and up to 24 months after treatment start |
| Secondary | Treatment Success According to Pyrazinamide Resistance (1) | At 24months after treatment start | Treatment success rate of participants with pyrazinamide resistance in the mITT analysis |
| Secondary | Proportion of Death Between the Control and Investigational Arms | At 24months after treatment start | The proportion of participants who died in the control and experimental arm mITT population |
| Secondary | Sputum Culture Conversion Proportion | At 6 months of treatment start | Culture conversion rate at month 6 of treatment in participants with positive baseline sputum culture (liquid media). |
| Secondary | Treatment Success According to Pyrazinamide Resistance (2) | At 24 months after treatment start | Treatment success rate of participants without pyrazinamide resistance in the mITT analysis |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Success Rate | 24 months after treatment start | mITT population Participant with \[not assessable\] was not included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Sputum Culture Conversion After Treatment Start | through study completion (24 months after treatment start) | Participants with a positive baseline M.tuberculosis culture (liquid media) in the mITT population | day | MEDIAN |
| SECONDARY | Sputum Culture Conversion Proportion | At 2 months of treatment | mITT population Participants with positive baseline sputum culture | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Success at the End of Treatment | At the end of treatment | mITT populration One participant of experimental arm who became pregnant during the treatment was excluded | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Reverting to Positive Sputum Culture After the End of Treatment | At 24months after treatment start | mITT population Participant with \[not assessable\] was not included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Success According to Pyrazinamide Resistance (1) | At 24months after treatment start | mITT population Participant with \[not assessable\] was not included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Death Between the Control and Investigational Arms | At 24months after treatment start | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sputum Culture Conversion Proportion | At 6 months of treatment start | mITT population participants with positive baseline sputum culture (liquid media) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Success According to Pyrazinamide Resistance (2) | At 24 months after treatment start | mITT population Participant with \[not assessable\] was not included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Success Rate | Control Arm | 60 | Participants | ||
| Treatment Success Rate | Experimental Arm | 54 | Participants | ||
| Time to Sputum Culture Conversion After Treatment Start | Control Arm | 24 | Inter-Quartile Range 7 to 56 | day | |
| Time to Sputum Culture Conversion After Treatment Start | Experimental Arm | 27 | Inter-Quartile Range 7 to 55 | day | |
| Sputum Culture Conversion Proportion | Control Arm | 42 | Participants | ||
| Sputum Culture Conversion Proportion | Experimental Arm | 35 | Participants | ||
| Treatment Success at the End of Treatment | Control Arm | 64 | Participants | ||
| Treatment Success at the End of Treatment | Experimental Arm | 61 | Participants | ||
| Proportion of Reverting to Positive Sputum Culture After the End of Treatment | Control Arm | 0 | Participants | ||
| Proportion of Reverting to Positive Sputum Culture After the End of Treatment | Experimental Arm | 1 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Arm | 106 | |
| Overall Study | STARTED | Experimental Arm | 108 | |
| Overall Study | COMPLETED | Control Arm | 89 | |
| Overall Study | COMPLETED | Experimental Arm | 79 | |
| Overall Study | NOT COMPLETED | Control Arm | 17 | |
| Overall Study | NOT COMPLETED | Experimental Arm | 29 |
Source ClinicalTrials.gov
Adverse events526
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 | Control Arm | 6 | 89 | |
| other | Anaemia | Blood and lymphatic system disorders | Experimental Arm | 29 | 79 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Control Arm | 0 | 89 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Experimental Arm | 1 | 79 | |
| other | Leukopenia | Blood and lymphatic system disorders | Control Arm | 0 | 89 | |
| other | Leukopenia | Blood and lymphatic system disorders | Experimental Arm | 2 | 79 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Control Arm | 1 | 89 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Experimental Arm | 0 | 79 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Control Arm | 0 | 89 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Experimental Arm | 4 | 79 |
1 to 10 of 526Source ClinicalTrials.gov
See all 526 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Arm | 2 | 89 |
| Total, all-cause mortality | Experimental Arm | 5 | 79 |
| Total, other adverse events | Control Arm | 87 | 89 |
| Total, other adverse events | Experimental Arm | 78 | 79 |
| Total, serious adverse events | Control Arm | 19 | 89 |
| Total, serious adverse events | Experimental Arm | 20 | 79 |
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental Arm vs Control Arm: Proportion of Reverting to Positive Sputum Culture After the End of Treatment | Trial comparisons |
| Experimental Arm vs Control Arm: Sputum Culture Conversion Proportion | Trial comparisons |
| Experimental Arm vs Control Arm: Proportion of Death Between the Control and Investigational Arms | Trial comparisons |
| Experimental Arm vs Control Arm: Treatment Success at the End of Treatment | Trial comparisons |
| Experimental Arm vs Control Arm: Sputum Culture Conversion Proportion | Trial comparisons |
| Experimental Arm vs Control Arm: deaths from any cause | Trial comparisons |
| Experimental Arm vs Control Arm: Treatment Success According to Pyrazinamide Resistance (2) | Trial comparisons |
| Experimental Arm vs Control Arm: Treatment Success According to Pyrazinamide Resistance (1) | Trial comparisons |
| Experimental Arm vs Control Arm: Treatment Success Rate | Trial comparisons |
| Experimental Arm vs Control Arm: 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/NCT02619994
GET https://conductscience.org/api/trials/v1/NCT02619994/events?page=2