TuberculosisPhase 2NCT05382312
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
A Phase 2 study testing GSK3036656, Bedaquiline and Delamanid in people with Tuberculosis, run by GlaxoSmithKline at 1 site in South Africa.
Trial summary
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or standard of care, for 14 days, in participants with newly diagnosed sputum smear positive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- GSK3036656, Bedaquiline and Delamanid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSouth Africa
- Study dates
- 26 Jul 2022to 27 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Participants had:
- A new episode of untreated, rifampicin-susceptible pulmonary tuberculosis (TB)
- A chest X-ray picture consistent with pulmonary TB
- At least one sputum sample positive on direct microscopy for acid-fast bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease [IUATLD]/World Health Organization [WHO] scale) or positive on a molecular test (at least medium positive for MTB on Xpert MTB/Rif)
- A normal echocardiogram, or an echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation, and no valvular stenosis
Show all 10Show fewer
- A creatinine clearance greater than or equal to (>=) 90 mL/minute (Cockcroft-Gault formula)
- Male participants were eligible to participate if they agreed to barrier precautions until 90 days after the last dose.
- A female participant was eligible to participate if she was not pregnant or breastfeeding and was a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) using a highly effective contraceptive method. A WOCBP had to have a negative urine or serum pregnancy test, as required by local regulations, before the first dose of study intervention. Only participants who were at least 25 years of age, and females of non-childbearing potential, were eligible for the positron emission tomography-computed tomography (PET-CT) assessments.
- Participants were capable of giving signed informed consent.
Who cannot join
- There was evidence of a clinically significant condition or abnormality (as judged by the Investigator) (other than the indication being studied) that might have compromised safety or the interpretation of trial efficacy or safety endpoints.
- There was clinically significant evidence of extrathoracic TB, as judged by the Investigator.
- QTc interval corrected for heart rate by Fridericia's formula (QTcF) was greater than (>) 450 milliseconds (msec).
- There was arterial hypertension with systolic BP >=160 mm Hg or diastolic BP >=100 mm Hg. Participants with well-controlled hypertension could be included if they were using amlodipine for the duration of the study.
- Participants had vitiligo.
- Participants were receiving QT-prolonging drugs, including but not limited to fluoroquinolones, macrolides, and clofazimine.
Show all 15Show fewer
- HIV-infected participants who:
- had a cluster of differentiation (CD)4+ count <350 cells/microliters;
- had received antiretroviral therapy medication within the last 30 days;
- had received oral or intravenous antifungal medication within the last 30 days;
- or had an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection or malignancy in the last 12 months (except pulmonary TB).
- Hepatitis B surface antigen (HBsAg) was present, or the Hepatitis C antibody test result at screening was positive.
- Participants had diabetes (Type 1 or 2), point-of-care glycated hemoglobin (HbA1c) above 6.5%, or random glucose over 11.1 millimoles (mmol)/L.
- There were diseases or conditions in which the use of delamanid or bedaquiline was contraindicated.
- Participants had abnormal laboratory values at screening, as graded by the enhanced Common Terminology Criteria for Adverse Events (CTCAE version 5, 2017).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or standard of care, for 14 days, in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.
- Conditions
- Tuberculosis
- Being tested
- GSK3036656, Bedaquiline, Delamanid, RIFAFOUR e-275, BTZ-043
- Keywords
- Early bactericidal activity, Pulmonary tuberculosis, RIFAFOUR, Bedaquiline, Delamanid, GSK3036656, BTZ-043
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3036656Drug
GSK3036656 was administered.
BedaquilineDrug
Bedaquiline was administered.
DelamanidDrug
Delamanid was administered.
RIFAFOUR e-275Drug
RIFAFOUR e-275 was administered.
BTZ-043Drug
BTZ-043 was administered.
PretomanidDrug
Pretomanid was administered.
LinezolidDrug
Linezolid was administered.
MoxifloxacinDrug
Moxifloxacin was administered.
| Study group | Role | What they receive |
|---|---|---|
| GSK3036656 + Bedaquiline | Experimental | Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14). Receives: Drug: GSK3036656; Drug: Bedaquiline |
| GSK3036656 + Delamanid | Experimental | Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. Receives: Drug: GSK3036656; Drug: Delamanid |
| Delamanid + Bedaquiline | Experimental | Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14). Receives: Drug: Bedaquiline; Drug: Delamanid |
| Standard of care for drug-sensitive tuberculosis (DS - TB)_Cohort 1 | Experimental | Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days. Receives: Drug: RIFAFOUR e-275 |
| GSK3036656 + BTZ-043 | Experimental | Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. Receives: Drug: GSK3036656; Drug: BTZ-043 |
| Standard of care for DS - TB_Cohort 2 | Experimental | Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days. Receives: Drug: RIFAFOUR e-275 |
| GSK3036656 + Pretomanid | Experimental | Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. Receives: Drug: GSK3036656; Drug: Pretomanid |
| GSK3036656 + Linezolid | Experimental | Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. Receives: Drug: GSK3036656; Drug: Linezolid |
| GSK3036656 + moxifloxacin | Experimental | Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. Receives: Drug: GSK3036656; Drug: Moxifloxacin |
| Standard of care for DS TB_Cohort 3 | Experimental | Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days. Receives: Drug: RIFAFOUR e-275 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
Measured: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
Secondary outcomes (10)
Change From Baseline in Time to Sputum Culture Positivity
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
Measured: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment.
Measured: From Day 1 to Day 28
Number of Participants With Adverse Events (AE) of Grade 3 Severity or Higher
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not it was considered related to the study intervention. The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1, where grades were defined based on numeric criteria as follows: Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicated greater severity.
Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 to Day 28
Number of Participants With Adverse Events Related to Study Treatment
Measured: From Day 1 to Day 28
Number of Participants Withdrawn From the Treatment Due to Adverse Events
Measured: From Day 1 to Day 28
Number of Participants Withdrawn From the Study Due to Adverse Events
Measured: From Day 1 to Day 28
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PCI ECG values were defined as any ECG findings which, in the opinion of the investigator or medical monitor, would have interfered with the safety of the individual participant. The ECG measurements analyzed were PR Interval, QRS Duration, and QTcF Interval. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Measured: From Day 1 to Day 28
Number of Participants With Hematology Laboratory Values of PCI
The analyzed hematology parameters were hematocrits, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Measured: From Day 1 to Day 28
Number of Participants With Clinical Chemistry Laboratory Values of PCI
The chemistry parameters analyzed were glucose, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, potassium, and sodium. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Measured: From Day 1 to Day 28
Number of Participants With Vital Signs of PCI
The analyzed vital signs were systolic blood pressure, diastolic blood pressure, pulse rate. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Measured: From Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start26 Jul 2022
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Click-TB Consortium
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382312
- Sponsor's protocol ID
- 214912
- Status last verified
- May 2026
- First submitted
- 16 May 2022
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT05382312
- Acronym / sponsor ID
- 214912
- Conditions
- Tuberculosis
- Keywords
- Early bactericidal activity, Pulmonary tuberculosis, RIFAFOUR, Bedaquiline, Delamanid, GSK3036656, BTZ-043
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Click-TB Consortium
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or standard of care, for 14 days, in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| GSK3036656 + Bedaquiline | Experimental | Drug: GSK3036656, Drug: BedaquilineParticipants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14). |
| GSK3036656 + Delamanid | Experimental | Drug: GSK3036656, Drug: DelamanidParticipants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. |
| Delamanid + Bedaquiline | Experimental | Drug: Bedaquiline, Drug: DelamanidParticipants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14). |
| Standard of care for drug-sensitive tuberculosis (DS - TB)_Cohort 1 | Experimental | Drug: RIFAFOUR e-275Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days. |
| GSK3036656 + BTZ-043 | Experimental | Drug: GSK3036656, Drug: BTZ-043Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. |
| Standard of care for DS - TB_Cohort 2 | Experimental | Drug: RIFAFOUR e-275Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days. |
| GSK3036656 + Pretomanid | Experimental | Drug: GSK3036656, Drug: PretomanidParticipants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. |
| GSK3036656 + Linezolid | Experimental | Drug: GSK3036656, Drug: LinezolidParticipants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. |
| GSK3036656 + moxifloxacin | Experimental | Drug: GSK3036656, Drug: MoxifloxacinParticipants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1. |
| Standard of care for DS TB_Cohort 3 | Experimental | Drug: RIFAFOUR e-275Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants were 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Participants had:
- Male participants were eligible to participate if they agreed to barrier precautions until 90 days after the last dose.
- A female participant was eligible to participate if she was not pregnant or breastfeeding and was a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) using a highly effective contraceptive method. A WOCBP had to have a negative urine or serum pregnancy test, as required by local regulations, before the first dose of study intervention. Only participants who were at least 25 years of age, and females of non-childbearing potential, were eligible for the positron emission tomography-computed tomography (PET-CT) assessments.
- Participants were capable of giving signed informed consent.
Key exclusion criteria (15 listed)
- There was evidence of a clinically significant condition or abnormality (as judged by the Investigator) (other than the indication being studied) that might have compromised safety or the interpretation of trial efficacy or safety endpoints.
- There was clinically significant evidence of extrathoracic TB, as judged by the Investigator.
- QTc interval corrected for heart rate by Fridericia's formula (QTcF) was greater than (>) 450 milliseconds (msec).
- There was arterial hypertension with systolic BP >=160 mm Hg or diastolic BP >=100 mm Hg. Participants with well-controlled hypertension could be included if they were using amlodipine for the duration of the study.
- Participants had vitiligo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK3036656GSK3036656 was administered. | Drug | GSK3036656 + BTZ-043, GSK3036656 + Bedaquiline, GSK3036656 + Delamanid, GSK3036656 + Linezolid, GSK3036656 + Pretomanid, GSK3036656 + moxifloxacin |
| BedaquilineBedaquiline was administered. | Drug | Delamanid + Bedaquiline, GSK3036656 + Bedaquiline |
| DelamanidDelamanid was administered. | Drug | Delamanid + Bedaquiline, GSK3036656 + Delamanid |
| RIFAFOUR e-275RIFAFOUR e-275 was administered. | Drug | Standard of care for DS - TB_Cohort 2, Standard of care for DS TB_Cohort 3, Standard of care for drug-sensitive tuberculosis (DS - TB)_Cohort 1 |
| BTZ-043BTZ-043 was administered. | Drug | GSK3036656 + BTZ-043 |
| PretomanidPretomanid was administered. | Drug | GSK3036656 + Pretomanid |
| LinezolidLinezolid was administered. | Drug | GSK3036656 + Linezolid |
| MoxifloxacinMoxifloxacin was administered. | Drug | GSK3036656 + moxifloxacin |
Primary outcome
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Time frame: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
10 secondary outcomes
Change From Baseline in Time to Sputum Culture Positivity
Time frame: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 to Day 28
Number of Participants With Adverse Events (AE) of Grade 3 Severity or Higher
Time frame: From Day 1 to Day 28
Number of Participants With Adverse Events Related to Study Treatment
Time frame: From Day 1 to Day 28
Number of Participants Withdrawn From the Treatment Due to Adverse Events
Time frame: From Day 1 to Day 28
Number of Participants Withdrawn From the Study Due to Adverse Events
Time frame: From Day 1 to Day 28
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
Time frame: From Day 1 to Day 28
Number of Participants With Hematology Laboratory Values of PCI
Time frame: From Day 1 to Day 28
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Time frame: From Day 1 to Day 28
Number of Participants With Vital Signs of PCI
Time frame: From Day 1 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK3036656, Bedaquiline and Delamanid in people with Tuberculosis, run by GlaxoSmithKline at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB) (time frame: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.