Could a 12-Week pill cocktail replace 6 months of TB treatment?
NCT ID NCT05556746
First seen Jun 24, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether a 12-week combination of four drugs (bedaquiline, clofazimine, pyrazinamide, and delamanid) works better than the standard 26-week treatment for drug-susceptible tuberculosis. About 94 adults with TB will be randomly assigned to either the short regimen or standard care. The main goal is to see how quickly the new combo clears TB bacteria from sputum, and to check for 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
- Bedaquiline, clofazimine, pyrazinamide, and delamanid
- What this could lead to
- If this works, it could point toward a much shorter, 12-week treatment for drug-susceptible tuberculosis, making it easier for patients to complete therapy.
- What could go wrong
- This is a small, early-phase trial with only 94 participants. The new regimen may not be as effective or safe as standard treatment, and results may not 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
-
94 people
The number who actually took part.
- Started
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Nov 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Informed consent obtained and signed. * Pulmonary TB diagnosed by Xpert MTB/RIF, Xpert MTB/RIF Ultra, Line Probe Assay (LPA), or mycobacterial culture. * Sputum positive for acid fast bacilli (at least 1+ grade on the WHO scale). * Pulmonary TB diagnosed without known INH resistance (by LPA or Xpert MTB/XDR) and without known RIF resistance (by either LPA or Xpert). Note that phenotypic DST for INH resistance was done on screening cultures (using MGIT). If baseline molecular or phenotypic test results that become available after enrollment detect resistance to INH or RIF, the participant was a late exclusion from the study. * Newly diagnosed with TB and have a history of being untreated for at least 6 months after cure from a previous episode of TB. * For participants living with HIV, CD4+ cell count ≥200 cells/mm3, obtained within 30 days prior to study entry. Enrollment of participants living with HIV was limited to no more than 20% of the total study population. * For participants living with HIV, must be currently receiving or planning to initiate ART at or before study week 8. * Laboratory values at study screening: * Alanine aminotransferase (ALT) ≤3x the upper limit of normal (ULN) * Total bilirubin ≤2.5 x ULN * Creatinine ≤2 x ULN * Potassium ≥3.5 mEq/L, ≤5.5 mEq/L * Absolute neutrophil count (ANC) ≥650/mm3 * Hemoglobin ≥7.0g/dL * Platelet count ≥50,000/mm3 * For females of reproductive potential, negative serum or urine pregnancy test within 5 days prior to entry and willingness to use effective contraception for the duration of the study. Female participants who are not of reproductive potential must have documentation of menopause, hysterectomy, or bilateral oophorectomy or bilateral tubal ligation. Acceptable forms of contraception include: condoms, intrauterine device or intrauterine system, cervical cap with spermicide, diaphragm with spermicide. * The initial 25% of enrollment (n = 39) was restricted to participants with mild or moderate disease, defined as having sputum with higher Xpert MTB/RIF cycle threshold (Ct) values (\> 17 cycles) and the absence of extensive lung disease on chest X-ray (involvement of at least half of the area of the entire thoracic cavity). Thereafter, all eligible patients were offered participation without a pause in enrollment. Exclusion Criteria: * More than 5 days of treatment directed against active TB for the current TB episode preceding study entry. * Current extrapulmonary TB (e.g. neurological, skeletal, abdominal, or nodal), not including pleural TB, in the opinion of the site investigator. * Pregnant or breastfeeding. * Weight \<30kg. * Inability to take oral medications. * Current or planned use of any drug known to severely prolong the QTc interval, including, but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, disopyramide, erthyromycin, moxifloxacin, procainamide, quinidine, or sotalol. * Current or planned use of one or more of the following HIV medications: HIV protease inhibitors, HIV non-nucleoside reverse transcriptase inhibitors, elvitegravir/cobicistat, or bictegravir. * Current or past use of clofazimine, bedaquiline or delamanid. * QTcF \>450ms for men or \>470 ms for women. * Current or history of known personal or family long QT syndrome. * Known allergy/sensitivity to components of study TB drugs or their formulation. Microbiologic confirmation of drug-susceptible TB is not always available at the time of enrollment. Enrolled individuals who are subsequently determined to meet either of the following criteria were classified as late exclusions and study treatment was discontinued. These participants were transitioned to routine care but requested to remain in study follow up for safety evaluations. A. Screening, baseline study, and Week 1 visit sputum cultures fail to grow M. tuberculosis. B. Resistance to RIF or INH is detected from baseline molecular or phenotypic testing results that become available after enrollment.
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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
-
GHESKIO
Port-au-Prince, Haiti
-
University of Cape Town
Cape Town, South Africa
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Other studies related to the condition(s) this trial covers.
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