Trial · NCT02754765
Evaluating Newly Approved Drugs for Multidrug-resistant TB
NCT02754765, Phase 3, Completed, Médecins Sans Frontières, France
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating Newly Approved Drugs for Multidrug-resistant TB. Trials, record NCT02754765. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02754765
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Newly Approved Drugs for Multidrug-resistant TB
- NCT number
- NCT02754765
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 754 participants, actual
- Lead sponsor
- Médecins Sans Frontières, France
- Conditions
- Tuberculosis, Multidrug-Resistant, Infection, Bacterial, Pulmonary Tuberculoses
- Interventions
- Bedaquiline, Delamanid, Clofazimine, Levofloxacin, Moxifloxacin, Linezolid, Pyrazinamide, Control arm MDR-TB regimen, consistent with WHO guidelines
- First posted
- 2016-04-28
- Last updated
- 2025-02-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Week 73 Efficacy | Week 73 after randomization | Proportion of participants with favorable outcome at week 73. A participant's outcome will be classified as favorable at week 73 if the outcome is not classified as unfavorable, and one of the following is true: * The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between weeks 65 and 73; * The last culture result (from a sputum sample collected between weeks 65 and 73) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable; * There is no culture result from a sputum sample collected between weeks 65 and 73 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable. |
| Secondary | Week 104 Efficacy | Week 104 after randomization | Proportion of participants with favorable outcome at week 104. • A participant's outcome will be classified as favorable at week 104 if the outcome is not classified as unfavorable, and one of the following is true: 1. The last two cultures are negative. These two cultures must be from sputum samples collected on separate visits, the latest between weeks 97 and 104; 2. The last culture result (from a sputum sample collected between weeks 97 and 104) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable; 3. There is no culture result from a sputum sample collected between weeks 97 and 104 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable. |
| Secondary | Early Treatment Response (culture conversion) | Week 8 after randomization | 1. Proportion of patients with culture conversion assessed in MGIT system (and LJ where possible): 2 consecutive negative cultures from specimens collected at 2 different visits; if there is a missing or contaminated culture between 2 negatives, the definition of conversion is still met; 2. Time to culture conversion: assessed in MGIT system (and LJ where possible): time from treatment initiation to first of 2 consecutive negative cultures; if there is a missing or contaminated culture between 2 negatives, the definition of conversion is still met; 3. Change in time to positivity (TTP) in MGIT over 8 weeks. |
| Secondary | Week 39 Efficacy | Week 39 after randomization | Proportion of participants with favorable outcome at week 39: • A participant's outcome will be classified as favorable at week 39 if the last culture result (from a sample collected between weeks 36 and 39) is negative; and the outcome is not classified as unfavorable. A participant's outcome will be classified as unfavorable at week 39 in case of: 1. In the experimental arm, addition or replacement of one or more drugs; 2. In the control arm, addition or replacement of two or more drugs; 3. Death from any cause; 4. At least one culture result (from a sample collected between weeks 36 and 39) is positive; 5. The patient is not assessable because the last available culture result is from a sample collected before week 36. |
| Secondary | Week 73 Survival | Week 73 after randomization | At 73 weeks, the proportion of patients who died of any cause |
| Secondary | Week 104 Survival | Week 104 after randomization | At 104 weeks, the proportion of patients who died of any cause |
| Secondary | Week 73 Safety | Week 73 after randomization | The proportion of participants with grade 3 or greater AEs and serious adverse events (SAEs) of any grade by 73 weeks |
| Secondary | Week 104 Safety | Week 104 after randomization | The proportion of participants with grade 3 or greater AEs and serious adverse events (SAEs) of any grade by 104 weeks |
| Secondary | Week 73 Safety: proportion of patients with AESIs | Week 73 after randomization | The proportion of patients with AESIs by 73 weeks |
| Secondary | Week 104 Safety: proportion of patients with AESIs | Week 104 after randomization | The proportion of patients with AESIs by 104 weeks |
Source ClinicalTrials.gov
Outcomes0
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/NCT02754765
GET https://conductscience.org/api/trials/v1/NCT02754765/registered