QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial.
Kelly E Dooley, Susan L Rosenkranz, Francesca Conradie...
https://pubmed.ncbi.nlm.nih.gov/33587897Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06476210
The Safety and Efficacy of BDL (Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Adults With Multi-drug Resistant or Rifampicin-Resistant Pulmonary Tuberculosis
Led by Beijing Chest Hospital · Updated on 2024-06-26
45
Participants Needed
7
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of a combination drug regimen called BDL, which includes bedaquiline, delamanid, and linezolid, for treating adults with multi-drug resistant or rifampicin-resistant pulmonary tuberculosis. This investigator-initiated trial aims to determine the percentage of participants with favorable treatment outcomes after 6 to 9 months of therapy and to assess the frequency and severity of any side effects or serious adverse events associated with this treatment. Participants will receive the BDL regimen for 6 months, with an option to extend treatment to 9 months if cultures remain positive between months 4 to 6. The study drugs include specific doses of bedaquiline, delamanid, and linezolid, administered according to a defined schedule. Safety and efficacy data will be collected throughout the treatment period, followed by a 12-month monitoring phase after treatment completion to track bacterial recurrence and other outcomes. During the study, participants will undergo regular assessments including sputum culture tests at baseline and various weeks during treatment to monitor bacterial response and side effects. Researchers will track adverse events and serious adverse events, treatment discontinuations, and overall health status. Follow-up visits will continue for one year after treatment ends to observe long-term outcomes. Total participation includes the treatment phase plus a year of follow-up to monitor sustained treatment effects and safety.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with multi-drug resistant or rifampicin-resistant pulmonary tuberculosis confirmed by recent laboratory tests within the last two months
- No prior use or less than 4 weeks use of bedaquiline, delamanid, or linezolid
- Positive mycobacterial culture result at baseline, or positive sputum smear with no effective anti-tuberculosis treatment given
- No history of respiratory failure, heart failure, or significant arrhythmias, with QTcF under 450ms
- Willingness to follow treatment and monitoring schedule and report adverse reactions
- Voluntary participation with signed informed consent
You will not qualify if you...
- Peripheral neuropathy of grade 3 or 4, or grade 1 or 2 expected to worsen
- Elevated liver enzymes (ALT or AST 3 times above normal) or bilirubin 2 times above normal
- Pregnant or planning pregnancy during treatment
- Participation in other drug trials within past 3 months
- Known congenital or acquired QT interval prolongation or QTc over 450 ms
- History of symptomatic arrhythmias or clinically relevant bradycardia
- Cardiac diseases that could cause arrhythmias such as severe hypertension or heart failure
- Untreated persistent hypothyroidism
- Electrolyte imbalances like low potassium, calcium, or magnesium
- Allergies to study drugs or related substances
- Body mass index below 17 kg/m2
- Poor performance status with expected survival under 6 months
- Expected need for surgery due to pulmonary disease during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 39 weeks depending on treatment requirements
Participants receive the BDL regimen consisting of bedaquiline, delamanid, and linezolid to treat multi-drug resistant or rifampicin-resistant pulmonary tuberculosis.
Visits at baseline, weeks 1, 2, 4, 6, 8, then every 4 weeks until week 26 or week 39
Follow-up
Duration - 12 months
Participants are monitored for bacterial recurrence and sputum culture conversion for 12 months after completing treatment.
Visits at 3, 6, 9, and 12 months after treatment completion
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
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Research Team
Y
Yuhong Liu, Ph.D
W
Wei Shu, Master
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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Published Research Related To This Trial
Bedaquiline plus delamanid for XDR tuberculosis.
Marie Lachâtre, Christophe Rioux, Damien Le Dû...
https://pubmed.ncbi.nlm.nih.gov/26973310Bedaquiline and delamanid for the treatment of multidrug-resistant tuberculosis: a multicentre cohort study in Korea.
Cheon Tae Kim, Tae-Ok Kim, Hong-Joon Shin...
https://pubmed.ncbi.nlm.nih.gov/29545276Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: focus on the safety.
Jing-Tao Gao, Juan Du, Gui-Hui Wu...
https://pubmed.ncbi.nlm.nih.gov/33736710Delamanid: a review of its use in patients with multidrug-resistant tuberculosis.
Hannah A Blair, Lesley J Scott
https://pubmed.ncbi.nlm.nih.gov/25404020Superior Efficacy of a Bedaquiline, Delamanid, and Linezolid Combination Regimen in a Mouse Tuberculosis Model.
Elise D Pieterman, Lina Keutzer, Aart van der Meijden...
https://pubmed.ncbi.nlm.nih.gov/33502537Contribution of the nitroimidazoles PA-824 and TBA-354 to the activity of novel regimens in murine models of tuberculosis.
Rokeya Tasneen, Kathy Williams, Opokua Amoabeng...
https://pubmed.ncbi.nlm.nih.gov/25331697In vitro and in vivo activities of the nitroimidazole TBA-354 against Mycobacterium tuberculosis.
A M Upton, S Cho, T J Yang...
https://pubmed.ncbi.nlm.nih.gov/25331696OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice.
Makoto Matsumoto, Hiroyuki Hashizume, Tatsuo Tomishige...
https://pubmed.ncbi.nlm.nih.gov/17132069Comparison of in vitro Susceptibility of Mycobacteria Against PA-824 to Identify Key Residues of Ddn, the Deazoflavin-Dependent Nitroreductase from Mycobacterium tuberculosis.
Fuzhen Zhang, Shanshan Li, Shuan Wen...
https://pubmed.ncbi.nlm.nih.gov/32210596