Trial · NCT02409290
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
NCT02409290, Phase 3, Completed, IUATLD, Inc; results first posted 2023-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB. Trials, record NCT02409290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02409290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
- NCT number
- NCT02409290
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 588 participants, actual
- Lead sponsor
- IUATLD, Inc
- Conditions
- MDR-TB
- Interventions
- Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine, Ethambutol, Pyrazinamide, Isoniazid, Prothionamide, Kanamycin, Levofloxacin, Bedaquiline
- First posted
- 2015-04-06
- Last updated
- 2023-09-28
- Results first posted
- 2023-09-28
- Limitations and caveats
- The main limitation of the trial is that the open-label design might have influenced decisions on regimen change, especially for non-bacteriological reasons.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) | 76 weeks | The primary efficacy outcome of the STREAM Stage 2 comparison is status at Week 76 i.e. the proportion of patients with a favourable outcome at Week 76 |
| Other | Favourable Outcome After Long-term Follow-up (132 Weeks) | Last efficacy visit, between 96 and 132 weeks | The proportion of patients with a favourable outcome at their last efficacy visit |
| Other | Proportion of Patients With Acquired Drug Resistance | 132 weeks | The proportion of patients with acquired drug resistance (any drug) |
| Other | Failure or Recurrence (FoR) | final efficacy week (between 96 and 132 weeks) | probable or definite failure or recurrence (FoR) |
| Other | Failure or Recurrence (FoR) | 132 weeks, control regimen (arm B) using concurrent controls only | The proportion of patients with failure or recurrence (FoR) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) | 76 weeks | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Favourable Outcome After Long-term Follow-up (132 Weeks) | Last efficacy visit, between 96 and 132 weeks | mITT population, assessable patients | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Proportion of Patients With Acquired Drug Resistance | 132 weeks | mITT population, excluding the long regimen (arm A) | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Failure or Recurrence (FoR) | final efficacy week (between 96 and 132 weeks) | mITT population, comparing oral to control regimen | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Failure or Recurrence (FoR) | 132 weeks, control regimen (arm B) using concurrent controls only | mITT population, control regimen (arm B) using only concurrent controls | 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 |
|---|---|---|---|---|---|
| STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) | Regimen A (Long Regimen) | 0 | Participants | ||
| STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) | Regimen B (Control Regimen) | 133 | Participants | ||
| STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) | Regimen C (Oral Regimen) | 162 | Participants | ||
| STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) | Regimen D (6-month Regimen) | 122 | Participants | ||
| Favourable Outcome After Long-term Follow-up (132 Weeks) | Regimen A (Long Regimen) | 17 | Participants | ||
| Favourable Outcome After Long-term Follow-up (132 Weeks) | Regimen B (Control Regimen) | 126 | Participants | ||
| Favourable Outcome After Long-term Follow-up (132 Weeks) | Regimen C (Oral Regimen) | 152 | Participants | ||
| Favourable Outcome After Long-term Follow-up (132 Weeks) | Regimen D (6-month Regimen) | 115 | Participants | ||
| Proportion of Patients With Acquired Drug Resistance | Regimen A (Long Regimen) | 0 | Participants | ||
| Proportion of Patients With Acquired Drug Resistance | Regimen B (Control Regimen) | 5 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen A (Long Regimen) | 32 | |
| Overall Study | STARTED | Regimen B (Control Regimen) | 202 | |
| Overall Study | STARTED | Regimen C (Oral Regimen) | 211 | |
| Overall Study | STARTED | Regimen D (6-month Regimen) | 143 | |
| Overall Study | COMPLETED | Regimen A (Long Regimen) | 0 | |
| Overall Study | COMPLETED | Regimen B (Control Regimen) | 187 | |
| Overall Study | COMPLETED | Regimen C (Oral Regimen) | 196 | |
| Overall Study | COMPLETED | Regimen D (6-month Regimen) | 134 | |
| Overall Study | NOT COMPLETED | Regimen A (Long Regimen) | 32 | |
| Overall Study | NOT COMPLETED | Regimen B (Control Regimen) | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events184
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 | Torsade de pointes/QT prolongation (SMQ) | Cardiac disorders | Regimen A (Long Regimen) | 2 | 32 | 2 |
| other | Torsade de pointes/QT prolongation (SMQ) | Cardiac disorders | Regimen B (Control Regimen) | 47 | 202 | 47 |
| other | Torsade de pointes/QT prolongation (SMQ) | Cardiac disorders | Regimen C (Oral Regimen) | 52 | 211 | 52 |
| other | Torsade de pointes/QT prolongation (SMQ) | Cardiac disorders | Regimen D (6-month Regimen) | 38 | 143 | 38 |
| other | Hepatic disorders (SMQ) | Hepatobiliary disorders | Regimen A (Long Regimen) | 3 | 32 | 3 |
| other | Hepatic disorders (SMQ) | Hepatobiliary disorders | Regimen B (Control Regimen) | 31 | 202 | 31 |
| other | Hepatic disorders (SMQ) | Hepatobiliary disorders | Regimen C (Oral Regimen) | 33 | 211 | 33 |
| other | Hepatic disorders (SMQ) | Hepatobiliary disorders | Regimen D (6-month Regimen) | 15 | 143 | 15 |
| other | Metabolism and nutrition disorders | Metabolism and nutrition disorders | Regimen A (Long Regimen) | 10 | 32 | 10 |
| other | Metabolism and nutrition disorders | Metabolism and nutrition disorders | Regimen B (Control Regimen) | 22 | 202 | 22 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen A (Long Regimen) | 0 | 32 |
| Total, all-cause mortality | Regimen B (Control Regimen) | 8 | 202 |
| Total, all-cause mortality | Regimen C (Oral Regimen) | 11 | 211 |
| Total, all-cause mortality | Regimen D (6-month Regimen) | 2 | 143 |
| Total, other adverse events | Regimen A (Long Regimen) | 21 | 32 |
| Total, other adverse events | Regimen B (Control Regimen) | 114 | 202 |
| Total, other adverse events | Regimen C (Oral Regimen) | 109 | 211 |
| Total, other adverse events | Regimen D (6-month Regimen) | 82 | 143 |
| Total, serious adverse events | Regimen A (Long Regimen) | 8 | 32 |
| Total, serious adverse events | Regimen B (Control Regimen) | 44 | 202 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers38
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 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/NCT02409290
GET https://conductscience.org/api/trials/v1/NCT02409290/events?page=2