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. This study is a prospective cohort clinical study. It is planned to enroll patients aged ≥12 years with RR/MTB-TB complicated by diabetes at our center. Guided by the results of rapid molecular drug susceptibility testing, both groups will be treated with a regimen consisting of bedaquiline, pretomanid, linezolid, and moxifloxacin for 6 months. The experimental group will be diabetic patients, and the control group will be non-diabetic patients. The efficacy and safety of the two groups will be evaluated to provide a basis for the treatment of a new short-course drug-resistant regimen for RR/MDR-TB in special populations in China.
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.
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.
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.
Cohort
Prospective
Not listed
End of treatment outcome
Number of individuals experiencing each tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up), assessed at the end of treatment by a clinician, based on culture results
Incidence of patients have sputum culture conversion rate of mycobacterium tuberculosis within 48 weeks after treatment completion
Frequency of any adverse events (AEs) and serious adverse events (SAEs) occurring during the treatment period
Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings.
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