Treatment of multi-drug resistant tuberculosis with a new drug regimen

The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)

This study is testing a new combination of drugs to see if it can help adults with multi-drug resistant tuberculosis feel better and improve their treatment results.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Chest Hospital (Academic / other)
• Locations: 7 sites (Hefei, Anhui and 6 other locations)
• Trial ID: NCT06476210 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a combination regimen of bedaquiline, delamanid, and linezolid in adults suffering from multi-drug resistant tuberculosis (MDR-TB) or rifampicin-resistant tuberculosis (RR-TB). Participants will receive the BDL regimen for a duration of 6 to 9 months, depending on their treatment response, with safety and efficacy data being closely monitored throughout the treatment period. The study will also assess the percentage of participants achieving favorable treatment outcomes and the frequency of adverse events associated with the regimen. A follow-up period of 12 months post-treatment will be conducted to gather additional data on patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed multi-drug resistant or rifampicin-resistant pulmonary tuberculosis.

Not a fit: Patients with a history of respiratory or heart failure, or those who have previously used the study medications for more than four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat forms of tuberculosis.

How similar studies have performed: Other studies have shown promise in using similar drug combinations for treating resistant tuberculosis, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria

* 1.A patient with multi-drug resistant/rifampicin-resistant pulmonary tuberculosis (MDR/RR-TB) with recent laboratory evidence (culture or molecular testing) within the last two months
* 2.Age 18 years above
* 3.No prior use of neither bedaquiline, delamanid, linezolid, or use for less than 4 weeks
* 4.Positive culture result for mycobacterial at baseline(regardless smear positive or negative). No anti-tuberculosis treatment received within one month.
* 5.For patients who don't have baseline sputum culture results,positive sputum smear and no effective anti-tuberculosis treatment administered
* 6\. No history of respiratory failure or heart failure, and no clinically significant manifestations of arrhythmia, with a QTcF under 450ms
* 7.Promise to adhere to the treatment and follow-up schedule, complete treatment monitoring, and promptly report adverse reactions to the responsible physician
* 8.Voluntarily participate in this study and sign the informed consent form

Exclusion Criteria

* 1.According to DMID, peripheral neuropathy is classified as grade 3 or 4. Alternatively, participants with grade 1 or 2 neuropathy, which the investigator believes may progress/worsen during the study
* 2.Elevation of ALT or AST ≥3 times the upper limit of normal, or elevation of total bilirubin and direct bilirubin ≥2 times the upper limit of normal
* 3.Pregnant women or those who intent to pregnant during treatment
* 4.Participants who have participated in other drug trials in the past three months
* 5.Known congenital QT interval prolongation or any disease prolonging the QT interval, or QTc\>450 ms
* 6.History of symptomatic arrhythmias or clinically relevant bradycardia
* 7.Any cardiac disease that could precipitate arrhythmias, such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure with decreased left ventricular ejection fraction
* 8.History of known, untreated, persistent hypothyroidism
* 9.Electrolyte disturbances, especially hypokalemia, hypocalcemia, or hypomagnesemia
* 10.History of allergy or known allergic reactions to any investigational drug or related substances
* 11.BMI\<17 kg/m2
* 12.Karnofsky performance score under 50, or as determined by the principal investigator, the anticipated survival of the participant is not expected to exceed 6 months
* 13.Participants expected to require surgical intervention following assessment of their pulmonary disease

Withdrawal Criteria

1. Serious adverse events caused by the intervention
2. Confirmed QTcF interval ≥ 500ms or clinically significant ventricular arrhythmias
3. The expert panel deems the continuation of this combination regimen inappropriate
4. The patient requests withdrawal

Where this trial is running

Hefei, Anhui and 6 other locations

• Anhui Chest Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Chest Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Wuhan Institute for Tuberculosis Control — Wuhan, Hubei, China (Not_yet_recruiting)
• Changsha Central Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Hunan Chest Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Shandong Public Health Clinical Center — Jinan, Shandong, China (Not_yet_recruiting)
• Public Health Clinical Meadical Center of Chengdu — Chengdu, Sichuan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Yuhong Liu, Ph.D — Beijing Chest Hostal
• Study coordinator: Yuhong Liu, Ph.D

Conditions Pulmonary Tuberculosis