Trial · NCT03896685

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

NCT03896685, Phase 3, Completed, Médecins Sans Frontières, France

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q). Trials, record NCT03896685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03896685

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)
NCT number: NCT03896685
Status: Completed
Phases: Phase 3
Enrollment: 323 participants, actual
Lead sponsor: Médecins Sans Frontières, France
Conditions: Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary Tuberculoses, Mycobacterial Infections, Bacterial Infections, Gram-Positive Bacterial Infections
Interventions: Bedaquiline 100 MG, Delamanid 50 MG Oral Tablet, Clofazimine 100 MG Oral Capsule, Linezolid 600Mg Tab, Control arm MDR-TB regimen, designed according to latest WHO guidelines
First posted: 2019-04-01
Last updated: 2025-02-10

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Week 73 Efficacy: Proportion of participants with favorable outcome at Week 73	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: 1. The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between Week 65 and Week 73; 2. The last culture result (from a sputum sample collected between Week 65 and Week 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; 3. There is no culture result from a sputum sample collected between Week 65 and Week 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: Proportion of participants with favorable outcome at Week 104	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 Week 97 and Week 104; 2. The last culture result (from a sputum sample collected between Week 97 and Week 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 Week 97 and Week 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 first 8 weeks.
Secondary	Week 39 Efficacy: Proportion of participants with favorable outcome at Week 39	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 all culture results from samples collected between Week 36 and Week 39 are 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 Week 36 and Week 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 Failure/Relapse	Week 73 after randomization	Proportion of participants with treatment failure/relapse. A participant's outcome will be classified as failure/relapse at Week 73 if: 1. In an experimental arm, addition or replacement of one or more drugs; 2. In the control arm, addition or replacement of two or more drugs; 3. Initiation of a new MDR-TB regimen after the end of the allocated study regimen and before Week 73; 4. At least one of the last two cultures, the latest between Week 65 and 73, is positive in the absence of cross contamination; 5. The last culture result between Week 65 and 73 is negative; and: there is no other post-baseline culture result or the penultimate culture is positive due to cross contamination; and bacteriological, radiological or clinical evolution is unfavorable; 6. There is no culture result between Week 65 and 73 or it is positive due to cross contamination; and: the most recent culture is negative; and bacteriological, radiological or clinical evolution is unfavorable.
Secondary	Week 104 Failure/Relapse	Week 104 after randomization	Proportion of participants with treatment failure/relapse. A participant's outcome will be classified as failure/relapse at Week 104 if: 1. In an experimental arm, addition or replacement of one or more drugs; 2. In the control arm, addition or replacement of two or more drugs; 3. Initiation of a new MDR-TB treatment regimen after the end of the allocated study regimen and before Week 104; 4. At least one of the last two cultures, the latest between Week 97 and 104, is positive in the absence of cross contamination; 5. The last culture result between Week 97 and 104 is negative; and: there is no other post-baseline culture result or the penultimate culture is positive due to cross contamination; and bacteriological, radiological or clinical evolution is unfavorable; 6. There is no culture result between Week 97 and 104 or it is positive due to cross contamination; and: the most recent culture is negative; and bacteriological, radiological or clinical evolution is unfavorable.
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 AEs and SAEs	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 AEs and SAEs	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

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

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.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38037119	DERIVED	PubMed
40683298	DERIVED	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03896685

GET https://conductscience.org/api/trials/v1/NCT03896685/registered

API reference For AI assistants