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)

Launched by BEIJING CHEST HOSPITAL · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment plan called BDL, which includes three medications—bedaquiline, delamanid, and linezolid—to help adults with multi-drug resistant or rifampicin-resistant pulmonary tuberculosis (a serious lung infection). The trial aims to see how effective this treatment is over 6 to 9 months and to check for any side effects that may occur during the treatment. Participants will be closely monitored for their health and safety throughout the study and will have a follow-up visit 12 months after completing the treatment.

To be eligible for this trial, participants must be at least 18 years old and have a recent positive test for multi-drug resistant or rifampicin-resistant tuberculosis. They should not have used any of the study medications before or have any serious heart or lung conditions. If someone joins the trial, they can expect to take the medications daily for the specified period and will need to attend regular check-ups to ensure their safety. This study is currently recruiting, so it's a good opportunity for those who meet the criteria to receive potentially helpful treatment while contributing to medical research.

Gender

ALL

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