Trial · NCT02589782
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
NCT02589782, Phase 2, Phase 3, Completed, Medecins Sans Frontieres, Netherlands
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s). Trials, record NCT02589782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02589782
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
- NCT number
- NCT02589782
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 552 participants, actual
- Lead sponsor
- Medecins Sans Frontieres, Netherlands
- Conditions
- Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, Pulmonary
- Interventions
- Bedaquiline, Pretomanid, Moxifloxacin, Linezolid, Clofazimine, Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
- First posted
- 2015-10-28
- Last updated
- 2024-05-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1:Percentage of patients with culture conversion in liquid media at 8 weeks post randomisation. | 8 weeks post randomisation | |
| Primary | Stage 1: Percentage of patients who discontinue treatment for any reason or die | 8 weeks post randomisation | |
| Primary | Stage 2: Percentage of patients with an unfavourable outcome (failure, death, recurrence, loss to follow-up) | 72 weeks post-randomisation | |
| Secondary | Stage 1: Percentage of patients with grade 3 or higher QT prolongation | within 8 weeks post randomisation | |
| Secondary | Stage 1: Percentage of patients experiencing at least one Serious Adverse Event (SAE) | within 8 weeks post randomisation | |
| Secondary | Stage 1:Percentage of patients experiencing at least one new grade 3 or higher Adverse Event | within 8 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with culture conversion | 12 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with an unfavourable outcome (i.e. failure, treatment discontinuation, death, loss to follow up) | 24 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with an unfavourable outcome (i.e. failure, treatment discontinuation, death, loss to follow up, still on treatment at censure and recurrence) | 108 weeks post randomisation | |
| Secondary | Stage 2: Median time to culture conversion | 108 weeks |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
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/NCT02589782
GET https://conductscience.org/api/trials/v1/NCT02589782/registered