Rifampicin-resistant/Multidrug-resistant Pulmonary TuberculosisNCT07191834
A Study on the Short - Course Treatment Regimen Containing Pretomanid for Diabetes Mellitus Complicated With Rifampicin - Resistant/Multidrug - Resistant Pulmonary Tuberculosis
An observational study of Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis and Type 2 Diabetes Mellitus (T2DM), run by Wuhan Pulmonary Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis, Type 2 Diabetes Mellitus (T2DM), Pretomanid
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Sep 2027
- How long will I take part?
- 48 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis, Type 2 Diabetes Mellitus (T2DM), Pretomanid
- Keywords
- pretomanid, T2DM, RR/MDR-TB
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| test group | Thirty patients with diabetes mellitus complicated by rifampicin-resistant/multidrug-resistant pulmonary tuberculosis received a 6-month short-course treatment regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. From the initiation of treatment to the end of the follow-up period, which lasted a total of 48 weeks, the treatment outcomes and adverse events were observed. | |
| Control group (Group A) | Thirty cases of patients with rifampicin-resistant/multidrug-resistant pulmonary tuberculosis without diabetes received a 6-month short-course treatment regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. From the initiation of treatment to the end of the follow - up period, which lasted for a total of 48 weeks, the treatment outcomes and adverse events were observed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 and 48 weeks after treatment initiation
Secondary outcomes (2)
Incidence of patients have sputum culture conversion rate of mycobacterium tuberculosis within 48 weeks after treatment completion
Measured: 12,24,36 and 48 weeks after treatment initiation
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.
Measured: From the initiation of treatment to the 48 - week follow - up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rifampicin-resistant/Multidrug-resistant Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- Wuhan Pulmonary Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191834
- Sponsor's protocol ID
- Wuhan Pulmonary H4
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No