Pulmonary TuberculosisPhase 4NCT06476210
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)
A Phase 4 study testing BDL regimen in people with Pulmonary Tuberculosis, run by Beijing Chest Hospital at 7 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- BDL regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesChina
- Study dates
- Jun 2024to Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- Serious adverse events caused by the intervention
- Confirmed QTcF interval ≥ 500ms or clinically significant ventricular arrhythmias
- The expert panel deems the continuation of this combination regimen inappropriate
- The patient requests withdrawal
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149
Yuohong Liu, Doctor, 13691187507, liuyuhong0516@126.com
Wei Shu, shuvim@qq.com
- Not yet recruiting
Changsha Central Hospital
Changsha, Hunan, 410000
Yi Pei, 13755109302, 1113284116@qq.com
Yi Pei
- Not yet recruiting
Hunan Chest Hospital
Changsha, Hunan, 410000
Zhongheng Yi, 13117318850, 46498321@qq.com
Zhongheng Yi
- Not yet recruiting
Public Health Clinical Meadical Center of Chengdu
Chengdu, Sichuan, 610000
Guihui Wu, 13056668540, wghwgh2584@sina.com
Guihui Wu
- Not yet recruiting
Anhui Chest Hospital
Hefei, Anhui, 230000
Hua Wang, 13395694530, 1726553540@qq.com
Hua Wang
- Not yet recruiting
Shandong Public Health Clinical Center
Jinan, Shandong, 250000
Yu Xiong, 15589995880, yiyiruguo@163.com
Yu Xiong
- Not yet recruiting
Wuhan Institute for Tuberculosis Control
Wuhan, Hubei, 430000
Juan Du
Juan Du
About this study
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:
Read more
- What is the percentage of participants with favorable treatment outcome at the end of treatment?
- 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
- Pulmonary Tuberculosis
- Being tested
- BDL regimen
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDL regimenDrug
Drug:bedaquiline 100mg tablets
Other Names:
Bdq TMC-207 bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week
Drug:delamanid 50mg tablets
Other Names:
Dlm OPC-67683 delamanid 100mg 2 times daily
Drug:linezolid Scored 600mg tablets
Other Names:
Lzd linezolid 600mg once daily
| Study group | Role | What they receive |
|---|---|---|
| BDL interventionv group | Experimental | Not described Receives: Drug: BDL regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy outcome at the end of treatment
The efficacy outcome of treatment: bacteriological positive patients completed the prescribed treatment course, demonstrating bacteriological response without evidence of treatment failure Notes: bacteriological outcome response:bacterial culture conversion to negative and no recurrence of positivity thereafter Bacteriological conversion refers to confirmed tuberculosis patients having two or more consecutive negative sputum culture results, with at least a 7-day interval between each Recurrence of positivity refers to two or more consecutive sputum cultures were positive after bacteriological conversion, with at least a 7-day interval between each
Measured: Baseline (within 9 days before treatment initiation), weeks 1, 2, 4, 6, 8 of treatment, thereafter every 4 weeks until week 26(or 39 weeks for patients require prolonged treatment) during the intervention
Frequency of any adverse events (AEs) and serious adverse events (SAEs) occurring during the treatment period
Measured: Baseline (within 9 days before treatment initiation), weeks 1-16, 20 and 26 during the intervention
Secondary outcomes (3)
Incidence of patients have bacterial recurrence within 12 months after treatment completion
Measured: 3,6,9,12 months after the intervention
Time for sputum culture conversion to stable negativity during treatment
Measured: 3,6,9,12 months after the intervention
Proportion of patients who discontinued treatment due to adverse reactions or permanently unable to take the medication
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Public Health Clinical Center, Wuhan Institute for Tuberculosis Control, Changsha Central Hospital, Anhui Chest Hospital, Hunan Chest Hospital, Shandong Public Health Clinical Center
- Responsible party
- Sponsor
- Investigators
- Yuhong Liu, Ph.D, Principal investigator, Beijing Chest HostalMengqiu Gao, Ph.D, Principal investigator, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476210
- Sponsor's protocol ID
- YNLX-2024-009
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dooley KE, Rosenkranz SL, Conradie F, Moran L, Hafner R, von Groote-Bidlingmaier F, Lama JR, Shenje J, De Los Rios J, Comins K, Morganroth J, Diacon AH, Cramer YS, Donahue K, Maartens G; AIDS Clinical Trials Group (ACTG) A5343 DELIBERATE Study Team. QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial. Lancet Infect Dis. 2021 Jul;21(7):975-983. doi: 10.1016/S1473-3099(20)30770-2. Epub 2021 Feb 12.
PubMed 33587897Lachatre M, Rioux C, Le Du D, Frechet-Jachym M, Veziris N, Bouvet E, Yazdanpanah Y. Bedaquiline plus delamanid for XDR tuberculosis. Lancet Infect Dis. 2016 Mar;16(3):294. doi: 10.1016/S1473-3099(16)00047-5. No abstract available.
PubMed 26973310Kim CT, Kim TO, Shin HJ, Ko YC, Hun Choe Y, Kim HR, Kwon YS. Bedaquiline and delamanid for the treatment of multidrug-resistant tuberculosis: a multicentre cohort study in Korea. Eur Respir J. 2018 Mar 22;51(3):1702467. doi: 10.1183/13993003.02467-2017. Print 2018 Mar.
PubMed 29545276Gao JT, Du J, Wu GH, Pei Y, Gao MQ, Martinez L, Fan L, Chen W, Xie L, Chen Y, Wang H, Jin L, Li GB, Zong PL, Xiong Y, Wu QH, Li MW, Yan XF, Miao YF, Cai QS, Li XJ, Bai DP, Geng SJ, Yang GL, Tang PJ, Zeng Y, Chen XH, Li TX, Cai C, Zhou Y, Zhuo M, Wang JY, Guan WL, Xu L, Shi JC, Shu W, Cheng LL, Teng F, Ning YJ, Xie SH, Sun YX, Zhang LJ, Liu YH. Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: focus on the safety. Infect Dis Poverty. 2021 Mar 19;10(1):32. doi: 10.1186/s40249-021-00819-2.
PubMed 33736710Blair HA, Scott LJ. Delamanid: a review of its use in patients with multidrug-resistant tuberculosis. Drugs. 2015 Jan;75(1):91-100. doi: 10.1007/s40265-014-0331-4.
PubMed 25404020Pieterman ED, Keutzer L, van der Meijden A, van den Berg S, Wang H, Zimmerman MD, Simonsson USH, Bax HI, de Steenwinkel JEM. Superior Efficacy of a Bedaquiline, Delamanid, and Linezolid Combination Regimen in a Mouse Tuberculosis Model. J Infect Dis. 2021 Sep 17;224(6):1039-1047. doi: 10.1093/infdis/jiab043.
PubMed 33502537Tasneen R, Williams K, Amoabeng O, Minkowski A, Mdluli KE, Upton AM, Nuermberger EL. Contribution of the nitroimidazoles PA-824 and TBA-354 to the activity of novel regimens in murine models of tuberculosis. Antimicrob Agents Chemother. 2015 Jan;59(1):129-35. doi: 10.1128/AAC.03822-14. Epub 2014 Oct 20.
PubMed 25331697Upton AM, Cho S, Yang TJ, Kim Y, Wang Y, Lu Y, Wang B, Xu J, Mdluli K, Ma Z, Franzblau SG. In vitro and in vivo activities of the nitroimidazole TBA-354 against Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2015 Jan;59(1):136-44. doi: 10.1128/AAC.03823-14. Epub 2014 Oct 20.
PubMed 25331696Matsumoto M, Hashizume H, Tomishige T, Kawasaki M, Tsubouchi H, Sasaki H, Shimokawa Y, Komatsu M. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006 Nov;3(11):e466. doi: 10.1371/journal.pmed.0030466.
PubMed 17132069Zhang F, Li S, Wen S, Zhang T, Shang Y, Huo F, Xue Y, Li L, Pang Y. Comparison of in vitro Susceptibility of Mycobacteria Against PA-824 to Identify Key Residues of Ddn, the Deazoflavin-Dependent Nitroreductase from Mycobacterium tuberculosis. Infect Drug Resist. 2020 Mar 11;13:815-822. doi: 10.2147/IDR.S240716. eCollection 2020.
PubMed 32210596Stinson K, Kurepina N, Venter A, Fujiwara M, Kawasaki M, Timm J, Shashkina E, Kreiswirth BN, Liu Y, Matsumoto M, Geiter L. MIC of Delamanid (OPC-67683) against Mycobacterium tuberculosis Clinical Isolates and a Proposed Critical Concentration. Antimicrob Agents Chemother. 2016 May 23;60(6):3316-22. doi: 10.1128/AAC.03014-15. Print 2016 Jun.
PubMed 26976868Keller PM, Homke R, Ritter C, Valsesia G, Bloemberg GV, Bottger EC. Determination of MIC distribution and epidemiological cutoff values for bedaquiline and delamanid in Mycobacterium tuberculosis using the MGIT 960 system equipped with TB eXiST. Antimicrob Agents Chemother. 2015 Jul;59(7):4352-5. doi: 10.1128/AAC.00614-15. Epub 2015 May 4.
PubMed 25941226Liu Y, Matsumoto M, Ishida H, Ohguro K, Yoshitake M, Gupta R, Geiter L, Hafkin J. Delamanid: From discovery to its use for pulmonary multidrug-resistant tuberculosis (MDR-TB). Tuberculosis (Edinb). 2018 Jul;111:20-30. doi: 10.1016/j.tube.2018.04.008. Epub 2018 May 3.
PubMed 30029909Conradie F, Diacon AH, Ngubane N, Howell P, Everitt D, Crook AM, Mendel CM, Egizi E, Moreira J, Timm J, McHugh TD, Wills GH, Bateson A, Hunt R, Van Niekerk C, Li M, Olugbosi M, Spigelman M; Nix-TB Trial Team. Treatment of Highly Drug-Resistant Pulmonary Tuberculosis. N Engl J Med. 2020 Mar 5;382(10):893-902. doi: 10.1056/NEJMoa1901814.
PubMed 32130813Trebucq A, Schwoebel V, Kashongwe Z, Bakayoko A, Kuaban C, Noeske J, Hassane S, Souleymane B, Piubello A, Ciza F, Fikouma V, Gasana M, Ouedraogo M, Gninafon M, Van Deun A, Cirillo DM, Koura KG, Rieder HL. Treatment outcome with a short multidrug-resistant tuberculosis regimen in nine African countries. Int J Tuberc Lung Dis. 2018 Jan 1;22(1):17-25. doi: 10.5588/ijtld.17.0498. Epub 2017 Nov 17.
PubMed 29149917
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06476210
- Acronym / sponsor ID
- YNLX-2024-009
- Conditions
- Pulmonary Tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Collaborators
- Chengdu Public Health Clinical Center, Wuhan Institute for Tuberculosis Control, Changsha Central Hospital, Anhui Chest Hospital, Hunan Chest Hospital, Shandong Public Health Clinical Center
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the percentage of participants with favorable treatment outcome at the end of treatment?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BDL interventionv group | Experimental | Drug: BDL regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDL regimenDrug:bedaquiline 100mg tablets Other Names: Bdq TMC-207 bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week Drug:delamanid 50mg tablets Other Names: Dlm OPC-67683 delamanid 100mg 2 times daily Drug:linezolid Scored 600mg tablets Other Names: Lzd linezolid 600mg once daily | Drug | BDL interventionv group |
Primary outcome
The efficacy outcome at the end of treatment
Time frame: Baseline (within 9 days before treatment initiation), weeks 1, 2, 4, 6, 8 of treatment, thereafter every 4 weeks until week 26(or 39 weeks for patients require prolonged treatment) during the intervention
The efficacy outcome of treatment: bacteriological positive patients completed the prescribed treatment course, demonstrating bacteriological response without evidence of treatment failure Notes: bacteriological outcome response:bacterial culture conversion to negative and no recurrence of positivity thereafter Bacteriological conversion refers to confirmed tuberculosis patients having two or more consecutive negative sputum culture results, with at least a 7-day interval between each Recurrence of positivity refers to two or more consecutive sputum cultures were positive after bacteriological conversion, with at least a 7-day interval between each
Frequency of any adverse events (AEs) and serious adverse events (SAEs) occurring during the treatment period
Time frame: Baseline (within 9 days before treatment initiation), weeks 1-16, 20 and 26 during the intervention
3 secondary outcomes
Incidence of patients have bacterial recurrence within 12 months after treatment completion
Time frame: 3,6,9,12 months after the intervention
Time for sputum culture conversion to stable negativity during treatment
Time frame: 3,6,9,12 months after the intervention
Proportion of patients who discontinued treatment due to adverse reactions or permanently unable to take the medication
Time frame: during the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 33587897Dooley KE, Rosenkranz SL, Conradie F, Moran L, Hafner R, von Groote-Bidlingmaier F, Lama JR, Shenje J, De Los Rios J, Comins K, Morganroth J, Diacon AH, Cramer YS, Donahue K, Maartens G; AIDS Clinical Trials Group (ACTG) A5343 DELIBERATE Study Team. QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial. Lancet Infect Dis. 2021 Jul;21(7):975-983. doi: 10.1016/S1473-3099(20)30770-2. Epub 2021 Feb 12.
- Background: PubMed 26973310Lachatre M, Rioux C, Le Du D, Frechet-Jachym M, Veziris N, Bouvet E, Yazdanpanah Y. Bedaquiline plus delamanid for XDR tuberculosis. Lancet Infect Dis. 2016 Mar;16(3):294. doi: 10.1016/S1473-3099(16)00047-5. No abstract available.
- Background: PubMed 29545276Kim CT, Kim TO, Shin HJ, Ko YC, Hun Choe Y, Kim HR, Kwon YS. Bedaquiline and delamanid for the treatment of multidrug-resistant tuberculosis: a multicentre cohort study in Korea. Eur Respir J. 2018 Mar 22;51(3):1702467. doi: 10.1183/13993003.02467-2017. Print 2018 Mar.
- Background: PubMed 33736710Gao JT, Du J, Wu GH, Pei Y, Gao MQ, Martinez L, Fan L, Chen W, Xie L, Chen Y, Wang H, Jin L, Li GB, Zong PL, Xiong Y, Wu QH, Li MW, Yan XF, Miao YF, Cai QS, Li XJ, Bai DP, Geng SJ, Yang GL, Tang PJ, Zeng Y, Chen XH, Li TX, Cai C, Zhou Y, Zhuo M, Wang JY, Guan WL, Xu L, Shi JC, Shu W, Cheng LL, Teng F, Ning YJ, Xie SH, Sun YX, Zhang LJ, Liu YH. Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: focus on the safety. Infect Dis Poverty. 2021 Mar 19;10(1):32. doi: 10.1186/s40249-021-00819-2.
- Background: PubMed 25404020Blair HA, Scott LJ. Delamanid: a review of its use in patients with multidrug-resistant tuberculosis. Drugs. 2015 Jan;75(1):91-100. doi: 10.1007/s40265-014-0331-4.
- Background: PubMed 33502537Pieterman ED, Keutzer L, van der Meijden A, van den Berg S, Wang H, Zimmerman MD, Simonsson USH, Bax HI, de Steenwinkel JEM. Superior Efficacy of a Bedaquiline, Delamanid, and Linezolid Combination Regimen in a Mouse Tuberculosis Model. J Infect Dis. 2021 Sep 17;224(6):1039-1047. doi: 10.1093/infdis/jiab043.
- Background: PubMed 25331697Tasneen R, Williams K, Amoabeng O, Minkowski A, Mdluli KE, Upton AM, Nuermberger EL. Contribution of the nitroimidazoles PA-824 and TBA-354 to the activity of novel regimens in murine models of tuberculosis. Antimicrob Agents Chemother. 2015 Jan;59(1):129-35. doi: 10.1128/AAC.03822-14. Epub 2014 Oct 20.
- Background: PubMed 25331696Upton AM, Cho S, Yang TJ, Kim Y, Wang Y, Lu Y, Wang B, Xu J, Mdluli K, Ma Z, Franzblau SG. In vitro and in vivo activities of the nitroimidazole TBA-354 against Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2015 Jan;59(1):136-44. doi: 10.1128/AAC.03823-14. Epub 2014 Oct 20.
- Background: PubMed 17132069Matsumoto M, Hashizume H, Tomishige T, Kawasaki M, Tsubouchi H, Sasaki H, Shimokawa Y, Komatsu M. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006 Nov;3(11):e466. doi: 10.1371/journal.pmed.0030466.
- Background: PubMed 32210596Zhang F, Li S, Wen S, Zhang T, Shang Y, Huo F, Xue Y, Li L, Pang Y. Comparison of in vitro Susceptibility of Mycobacteria Against PA-824 to Identify Key Residues of Ddn, the Deazoflavin-Dependent Nitroreductase from Mycobacterium tuberculosis. Infect Drug Resist. 2020 Mar 11;13:815-822. doi: 10.2147/IDR.S240716. eCollection 2020.
- Background: PubMed 26976868Stinson K, Kurepina N, Venter A, Fujiwara M, Kawasaki M, Timm J, Shashkina E, Kreiswirth BN, Liu Y, Matsumoto M, Geiter L. MIC of Delamanid (OPC-67683) against Mycobacterium tuberculosis Clinical Isolates and a Proposed Critical Concentration. Antimicrob Agents Chemother. 2016 May 23;60(6):3316-22. doi: 10.1128/AAC.03014-15. Print 2016 Jun.
- Background: PubMed 25941226Keller PM, Homke R, Ritter C, Valsesia G, Bloemberg GV, Bottger EC. Determination of MIC distribution and epidemiological cutoff values for bedaquiline and delamanid in Mycobacterium tuberculosis using the MGIT 960 system equipped with TB eXiST. Antimicrob Agents Chemother. 2015 Jul;59(7):4352-5. doi: 10.1128/AAC.00614-15. Epub 2015 May 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuhong Liu, Ph.D principal investigator
Beijing Chest Hostal
Mengqiu Gao, Ph.D principal investigator
Beijing Chest Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BDL regimen in people with Pulmonary Tuberculosis, run by Beijing Chest Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuhong Liu, Ph.D (86-13691187507, liuyuhong0516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy outcome at the end of treatment (time frame: Baseline (within 9 days before treatment initiation), weeks 1, 2, 4, 6, 8 of treatment, thereafter every 4 weeks until week 26(or 39 weeks for patients require prolonged treatment) during the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06476210, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.