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New TB drug cocktail shows promise in early trial

NCT ID NCT05382312

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called GSK3036656 in combination with other tuberculosis medications in 127 adults with newly diagnosed, drug-sensitive pulmonary TB. Participants received one of several two-drug combinations or standard care for 14 days, then switched to standard treatment. The goal was to measure how quickly the combinations killed TB bacteria in sputum and to check for safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GSK3036656 (an experimental drug) combined with other tuberculosis drugs (bedaquiline, delamanid, BTZ-043, pretomanid, linezolid, moxifloxacin) or standard care
What this could lead to
If successful, this could point toward shorter, more effective treatment combinations for drug-sensitive tuberculosis.
What could go wrong
This is an early Phase 2A trial with only 127 participants and a short 14-day treatment period. Results may not translate to long-term cure or apply to all TB patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

127 people

The number who actually took part.

Started

Jul 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants were 18 to 65 years of age inclusive, at the time of signing the informed consent. * Participants had: 1. A new episode of untreated, rifampicin-susceptible pulmonary tuberculosis (TB) 2. A chest X-ray picture consistent with pulmonary TB 3. 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) 4. A normal echocardiogram, or an echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation, and no valvular stenosis 5. 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. Exclusion Criteria: * 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. * HIV-infected participants who: 1. had a cluster of differentiation (CD)4+ count \<350 cells/microliters; 2. had received antiretroviral therapy medication within the last 30 days; 3. had received oral or intravenous antifungal medication within the last 30 days; 4. 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • GSK Investigational Site

    Bellville, 7530, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.