New 6-Month TB drug combo tested in diabetic patients
NCT ID NCT07191834
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a 6-month treatment regimen containing pretomanid for people with drug-resistant tuberculosis who also have type 2 diabetes. Researchers will compare how well the treatment works and how safe it is in diabetic patients versus non-diabetic patients. The goal is to see if this shorter, all-oral regimen is a good option for this high-risk group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pretomanid (combined with bedaquiline, linezolid, and moxifloxacin)
- What this could lead to
- If successful, this could show that a shorter, all-oral treatment works safely for people with both drug-resistant TB and diabetes, improving cure rates and reducing side effects.
- What could go wrong
- This is a small, early-stage study with only 60 participants, and results may not apply to all patients. People with diabetes may still experience more side effects or lower cure rates than expected.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 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.
Who is studied
RR/MDR-TB Patients will be divided into two groups based on the presence or diagnosis of diabetes. Experimental group: Patients diagnosed with diabetes. Control group: Patients with diabetes excluded.
- Ages
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12 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: * Voluntary participation. * Aged \>12 years, and weighing 30 kilograms or more. * Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an BPaL treatment regimen. * The diabetes group shall include patients who have been diagnosed with diabetes, either previously or currently. * Fertile women shall not be pregnant, voluntarily undergo a pregnancy test with a negative result, and be willing to use highly effective contraceptive measures from the time of signing the informed consent until three months after the end of the research treatment. * Fertile men shall use condoms or other methods to ensure effective contraception for their sexual partners. * Lactating women shall be willing to stop breastfeeding from the time of signing the informed consent until three months after the end of the research treatment. * Participants shall voluntarily undergo an HIV test. If the result is positive, they shall voluntarily accept antiretroviral therapy. Exclusion Criteria: * Previously received treatment with at least one of bedaquiline (BDQ) or delamanid (DLM) for more than 28 days. * Currently using prohibited medications specified in the research protocol, and the researcher believes that, from the perspective of patient benefit, the priority of continuing to use the medication is higher than participating in this study. * Known to have had a hypersensitivity reaction to any of the medications in the protocol. * Currently participating in any other clinical trials of medications. * At the time of screening, there is a risk of cardiovascular disease: QTcF interval exceeding 480 milliseconds; a history of arrhythmia considered clinically significant by the researcher within 60 days before enrollment, and the researcher believes that participation in the study may increase the risk; decompensated heart failure; grade 3 hypertension without reaching the control target; abnormal thyroid function; abnormal levels of serum calcium, magnesium, or potassium. * A history of optic neuropathy or peripheral neuropathy, and the researcher believes that progression/deterioration may occur during the study, or the participant is not suitable for the study. * At the time of screening, there are the following manifestations of liver diseases: active viral hepatitis; decompensated cirrhosis. * At the time of screening, there is a history of the following kidney diseases or manifestations related to kidney diseases: a history of unstable or rapidly progressive kidney disease; moderate/severe renal impairment or end - stage renal disease; serum creatinine ≥133 μmol/L in men and ≥124 μmol/L in women. * Other abnormal laboratory test results: hemoglobin level \<8.0 g/dL; platelet count \<75,000/mm³; absolute neutrophil count \<1000/mm³; aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>3×ULN; total bilirubin \>2×ULN, or \>1.5×ULN combined with other abnormal liver enzymes; albumin \<30 g/L. * The researcher believes that the study participant is unable to complete the study process, or participation in the study is unsafe for the study participant.
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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.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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