A Phase 4 interventional study of BDL regimen in Pulmonary Tuberculosis, sponsored by Beijing Chest Hospital. Recruiting at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Beijing Chest Hospital · Phase 4, Interventional, and Treatment
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Among 28 studies in Tuberculosis, Pulmonary with a site in China — 12 open to participants now, 14 under way, 6 of them phase 3. Tuberculosis, Pulmonary · China.
Among the 28 studies in Tuberculosis, Pulmonary with a site in China, this one is the 21st largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2024, is one of 6 in phase 4, reaches primary completion later than 2 of the 13 other live ones, and was the 20th registered.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
Browse Tuberculosis, Pulmonary studies →12 of the 28 studies in Tuberculosis, Pulmonary with a site in China are open now. Recruiting first, the newest first:
Huashan Hospital · Sites in China
Ages 3 mo–18 yrs
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18+
Shenzhen Third People's Hospital · Sites in China
Ages 18–65
ChromX Health · Sites in China
Ages 18–100 · Healthy volunteers
Peking University Third Hospital · Sites in China
Ages 35+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 46 Tuberculosis, Pulmonary studies recruiting now, 22 (48%) set no upper age limit and 20 (43%) stop at 75 or younger; 11 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 7 · Phase 4 6
First in 2008; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 45 is below the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Median enrollment 280 across the 21 interventional studies, 800 across the 7 observational. Of the 5 that completed or were terminated, 3 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 28 have an industry lead sponsor. The 10 most frequent:
Beijing Chest Hospital is the lead sponsor of 31 studies on the registry; 13 are open to participants now.
Beijing Chest Hospital has 6 studies filed under Tuberculosis, Pulmonary — fewer than ten, so there is no comparison to draw.
4 of the studies in Tuberculosis, Pulmonary with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06649721Phase 3Huashan HospitalInnovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort | 2027-02-28 |
| NCT07395596First Affiliated Hospital of Zhejiang UniversityRemimazolam for Bronchoscopy in High-Risk Patients | 2026-12 |
| NCT06528418ChromX HealthIdentification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath | 2026-12-30 |
| NCT07893444Huashan HospitalBRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children | 2027-11-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 28 studies in Tuberculosis, Pulmonary with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Withdrawal Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BDL regimen
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
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
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
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
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
Start is estimated for Jun 2024; primary completion for Jun 2025, 12 months later.
How these figures are worked out, and which studies are left out of them.
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Beijing Chest Hospital