Actively Recruiting
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)
Led by Beijing Chest Hospital · Updated on 2024-06-26
45
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing Chest Hospital
Lead Sponsor
C
Chengdu Public Health Clinical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary tuberculosis, in the context of Pretomanid not available in China. It will also learn about the safety of BDL regimen. The main questions it aims to answer are: 1. What is the percentage of participants with favorable treatment outcome at the end of treatment? 2. What are the frequency and degree of AE and SAE associated with BDL regimen? Participants will take Bedaquiline +Delamanid+ Linezolid for 6 months, option for 9 months for subjects who remain culture positive at month 4 to 6. Safety and efficacy data will be monitored and collected during treatment. A 12 month follow-up will be conducted after treatment completion.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and above
- Diagnosed with multi-drug resistant or rifampicin-resistant pulmonary tuberculosis confirmed by recent laboratory tests within the last 2 months
- No prior use or less than 4 weeks use of bedaquiline, delamanid, or linezolid
- Positive mycobacterial culture result at baseline; no anti-tuberculosis treatment within one month prior
- For patients without baseline sputum culture, positive sputum smear and no effective anti-tuberculosis treatment administered
- No history of respiratory failure or heart failure and no clinically significant arrhythmia with QTcF under 450 ms
- Agree to adhere to treatment and follow-up schedules, complete treatment monitoring, and report adverse reactions promptly
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Peripheral neuropathy classified as grade 3 or 4, or grade 1 or 2 that may worsen during the study
- Elevation of ALT or AST at least 3 times upper limit of normal, or total and direct bilirubin at least 2 times upper limit of normal
- Pregnant women or those intending to become pregnant during treatment
- Participation in other drug trials within the past 3 months
- Known congenital or acquired QT interval prolongation or QTc over 450 ms
- History of symptomatic arrhythmias or clinically relevant slow heart rate
- Cardiac diseases that may cause arrhythmias, such as severe hypertension, left ventricular hypertrophy, or heart failure with reduced ejection fraction
- Untreated, persistent hypothyroidism
- Electrolyte imbalances like low potassium, calcium, or magnesium
- Known allergies to any investigational drugs or related substances
- Body mass index under 17 kg/m2
- Karnofsky performance score under 50 or expected survival less than 6 months
- Expected need for surgical intervention for pulmonary disease
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Anhui Chest Hospital
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
3
Wuhan Institute for Tuberculosis Control
Wuhan, Hubei, China, 430000
Not Yet Recruiting
4
Changsha Central Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
5
Hunan Chest Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
6
Shandong Public Health Clinical Center
Jinan, Shandong, China, 250000
Not Yet Recruiting
7
Public Health Clinical Meadical Center of Chengdu
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
Research Team
Y
Yuhong Liu, Ph.D
CONTACT
W
Wei Shu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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