NCT07191834
A Study on the Short - Course Treatment Regimen Containing Pretomanid for Diabetes Mellitus Complicated With Rifampicin - Resistant/Multidrug - Resistant Pulmonary Tuberculosis
Not Yet Recruiting · Not specified · Wuhan Pulmonary Hospital · registry updated 2025-09-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The treatment of rifampicin-resistant/multidrug-resistant pulmonary tuberculosis (RR-TB) is characterized by a long treatment course, a high incidence of adverse reactions, a low cure rate, and a high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, the high incidence of adverse reactions, and the long treatment course, which lead to poor patient compliance. There is an urgent need for new, effective, safe, and short-course anti-drug-resistant regimens. A 6-month short-course oral regimen containing pretomanid was launched in 2020 and was approved for marketing in China in March 2025. Currently, there have been multi-center studies on the treatment of rifampicin-resistant/multidrug-resistant pulmonary tuberculosis with the pretomanid regimen initiated by investigator-initiated trials (IIT) in China, but there are no studies on special populations. The diabetic population belongs to a special population, has a relatively high incidence rate in China, and is at high risk of tuberculosis. During the treatment process, they may be more likely to experience adverse reactions and poor outcomes than ordinary patients....
Inclusion
- 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.
Exclusion
- 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.