A Phase 2 interventional study of Bedaquiline (BDQ) and Clofazimine (CFZ) in Tuberculosis, Pulmonary and HIV, sponsored by Brigham and Women's Hospital. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
The PRESCIENT trial is a Phase IIc, open-label, randomized trial that compared a 12-week regimen of bedaquiline (BDQ), clofazimine (CFZ), pyrazinamide (PZA), and delamanid (DLM) with standard treatment for drug-susceptible pulmonary tuberculosis (TB). Eligible participants were randomized in a 1:1 ratio to BDQ, CFZ, PZA, and DLM (BCZD) or standard anti-TB therapy.
Participants in the experimental arm with evidence of poor clinical response at the end of therapy were re-treated with standard TB therapy. The primary analysis is a superiority efficacy comparison of time to liquid culture conversion through 8 weeks in the experimental (BCZD) arm vs. the standard therapy arm. The other key secondary outcome is safety.
The PRESCIENT trial is a Phase IIc, open-label, randomized trial that compared a 12-week regimen of bedaquiline (BDQ), clofazimine (CFZ), pyrazinamide (PZA), and delamanid (DLM) with standard treatment for drug-susceptible pulmonary tuberculosis. Eligible participants were randomized in a 1:1 ratio to BDQ, CFZ, PZA, and DLM (BCZD) or standard anti-TB therapy. Randomization was stratified by presence of lung cavitation and HIV status.
Participants were randomized to one of two arms:
Arm 1 (Experimental): BDQ 200 mg for 12 weeks + PZA 1000 - 2000 mg (according to weight) for 12 weeks + CFZ 300 mg for 2 weeks, followed by 100 mg for 10 weeks + DLM 200 mg for 12 weeks, all given once daily.
Arm 2 (Standard of Care): Rifampicin (RIF), Isoniazid (INH), Ethambutol (EMB) and Pyrazinamide (PZA) for 8 weeks, followed by RIF and INH for 18 weeks.
Medications were given daily in fixed dose combinations at standard weight-based doses. Adherence was supported through automated reminders and monitored remotely in real time with Wisepill electronic adherence monitoring devices or with directly observed treatment. Participants in the experimental arm with evidence of poor clinical response were re-treated with standard TB therapy. The primary analysis is a superiority efficacy comparison of time to liquid culture conversion through 8 weeks in the experimental (BCZD) arm vs. the standard therapy (RHZE) arm. Participants had extended post-treatment follow up to evaluate clinical efficacy as a secondary composite outcome measure at 86 weeks after randomization (74 weeks after completion of experimental therapy, when most relapses are expected to occur). The other key secondary outcome is safety, measured as the proportion with new Grade 3 or higher adverse events; we focused on prolonged QT interval corrected using Fridericia's formula (QTcF) and hepatitis as adverse events of special interest. Through an efficient Phase IIc design, the PRESCIENT trial tested microbiological efficacy, evaluated safety, and detected treatment-emergent resistance with the ultra-short BCZD regimen.
The PRESCIENT trial aimed to enroll 156 adults, but accrual was paused due to funding constraints and then permanently stopped per a Data and Safety Monitoring Board (DSMB) recommendation on December 12, 2025 due to both low conditional power (0.54%) for the primary outcome and a trend towards higher unfavorable outcomes in Arm 1 (BCZD).
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 94 is below the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Laboratory values at study screening:
Exclusion Criteria:
Microbiologic confirmation of drug-susceptible TB is not always available at the time of enrollment. Enrolled individuals who are subsequently determined to meet either of the following criteria were classified as late exclusions and study treatment was discontinued. These participants were transitioned to routine care but requested to remain in study follow up for safety evaluations.
A. Screening, baseline study, and Week 1 visit sputum cultures fail to grow M. tuberculosis.
B. Resistance to RIF or INH is detected from baseline molecular or phenotypic testing results that become available after enrollment.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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 number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
BDQ 200 mg for 12 weeks + PZA 1000 - 2000 mg (according to weight) for 12 weeks + CFZ 300 mg for 2 weeks, followed by 100 mg for 10 weeks + DLM 200 mg for 12 weeks, all given once daily.
Drug: Bedaquiline (BDQ) · Drug: Clofazimine (CFZ) · Drug: Pyrazinamide (PZA) · Drug: Delamanid (DLM)
RIF, INH, EMB and PZA for 8 weeks, followed by RIF and INH for 18 weeks; given daily in fixed dose combinations at standard weight-based doses.
Drug: Rifampicin (RIF) · Drug: Isoniazid (INH) · Drug: Ethambutol (EMB) · Drug: Pyrazinamide (PZA)
Daily therapy for 12 weeks
Daily therapy for 12 weeks
Daily therapy for 12 weeks
Daily therapy for 12 weeks
Daily therapy for 26 weeks
Daily therapy for 26 weeks
Daily therapy for 8 weeks
Daily therapy for 8 weeks
Median Time to Stable Liquid Culture Conversion by Week 8
Culture conversion is defined as the first of two negative sputum cultures, consecutive or not, without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs or symptoms of active tuberculosis (TB).
Time frame: Measured through Week 8
Cumulative Probability of Experiencing Any Grade 3 or Higher Adverse Event (AE)
AEs include any occurrence that is new in onset or aggravated at least one-grade from baseline. AE's are graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017.
Time frame: Measured at Week 60
Cumulative Probability of Having a Favorable Composite Outcome
Favorable composite outcome is defined as no failure, relapse, or non-accidental death.
Time frame: Measured at Week 60
Proportion Who Prematurely Discontinue Treatment
Premature treatment discontinuation is defined as discontinuation other than due to violent death, natural disaster, or administrative censoring
Time frame: Measured at Week 12 in Arm 1 and Week 26 in Arm 2
Median Time to Stable Liquid Culture Conversion by Week 12
Culture conversion is defined as the first of two negative sputum cultures, consecutive or not, without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs or symptoms of active TB
Time frame: Measured through Week 12
Mean Change in Skin Coloration Since TB Treatment Started at Weeks 8, 12, 16, 26, 60, and 86
Participants rate any change in skin color since TB treatment started on subjective 10-point numeric rating scale where 0=none, 10=worst possible change in coloration.
Time frame: Weeks 8, 12, 16, 26, 60, and 86
Mean Distress Related to Skin Coloration Since TB Treatment Started at Weeks 8, 12, 16, 26, 60, and 86
Participants rate distress from change in skin color since TB treatment started on subjective 10-point numeric rating scale where 0=none, 10=worst possible distress due to coloration.
Time frame: Weeks 8, 12, 16, 26, 60, and 86
Mean Change in QTcF From Baseline to Week 1, 2, 4, 8, 12, and 16
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used at each of baseline (screening visit), Week 1, Week 2, Week 4, Week 8, Week 12, and Week 16.
Time frame: Baseline (screening visit) and weeks 1, 2, 4, 8, 12, and 16
Mean Change in QTcF From Baseline to End of Treatment
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used at baseline (screening visit) and week 12 (Arm 1). ECG was not required at week 26 per the protocol thus the week 26 data was not collected.
Time frame: Measured at Week 12 in Arm 1 and Week 26 in Arm 2
Occurrence of Absolute QTcF >480 ms and ≤500 ms, and >500 ms
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used through week 16 in Arm 1 and Arm 2
Time frame: Measured through Week 16
Occurrence of QTcF Change From Baseline of >30 ms and ≤60 ms, and >60 ms
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used at baseline (screening visit) and through week 16 in Arm 1 and Arm 2
Time frame: Measured through Week 16
Cumulative Probability of Having One or More Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but based upon appropriate medical judgment may jeopardize the participant and may require intervention to prevent one of the outcomes listed in the definition above.
Time frame: Measured through Week 86
Proportion With Culture Conversion in Liquid Media at Weeks 4, 8 and 12
Proportion of participants who have achieved stable culture conversion, defined as two negative sputum cultures, consecutive or not, without an intervening positive culture and/or visits wherein the participant is unable to produce sputum and has no signs of active TB; occurring before or at the week 4, 8, or 12 visit, respectively.
Time frame: Measured at Weeks 4, 8, and 12
Proportion With Culture Conversion in Solid Media at Weeks 4, 8 and 12
Proportion of participants who have achieved stable culture conversion, defined as two negative sputum cultures, consecutive or not, without an intervening positive culture and/or visits wherein the participant is unable to produce sputum and has no signs of active TB; occurring before or at the week 4, 8, or 12 visit, respectively.
Time frame: Measured at Weeks 4, 8, and 12
Cumulative Probability of TB Relapse (by M. Tuberculosis Genotyping)
For participants who had successful culture conversion through the end of study treatment, TB relapse is defined as a recurrence of TB emanating from the same strain as the participant's originally diagnosed TB, which will be determined through whole genome sequencing.
Time frame: Measured from end of treatment (week 12 for Arm 1 and week 26 for Arm2) through Week 86
Proportion of Treatment-emergent Genotypic and Phenotypic Resistance to BCZD
For participants in experimental group only. Minimum Inhibitory Concentration (MIC) values will be evaluated against resistance-associated variants (RAVs) for paired baseline and failure isolates. Frequencies and proportions with phenotypic and/or genotypic resistance to any drug will be reported.
Time frame: Measured through Week 86
Median Time (Days) to Positivity in Liquid Culture
Time to positivity in liquid culture is defined as the days required for a sample to exhibit detectable microbial growth (positive result) in liquid media. A shorter time to positivity indicates a higher concentration of viable microorganisms in the original sample. Participants with a negative liquid culture result were imputed to have the 'best' time to positivity of 43 days (\>42 days), and participants with contaminated culture results were excluded. Sputum samples were collected at weeks 1, 2, 3, 4, 6, and 8 for culture in liquid media.
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Participants were enrolled from November 24, 2023 to April 8, 2025 at two non-US clinical research sites.
| Milestone | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Started | 46 | 48 |
| Completed | 8 | 7 |
| Not completed | 38 | 41 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Went off study at week 60 or 72 due to funding constraints | 18 | 18 |
| Withdrew: Under study follow-up | 15 | 22 |
Culture conversion is defined as the first of two negative sputum cultures, consecutive or not, without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs or symptoms of active tuberculosis (TB).
| weeks | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Median Time to Stable Liquid Culture Conversion by Week 8 | 8 (1 to 8) | 6 (1 to 8) |
AEs include any occurrence that is new in onset or aggravated at least one-grade from baseline. AE's are graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017.
Results for this outcome have not been posted.
Favorable composite outcome is defined as no failure, relapse, or non-accidental death.
Results for this outcome have not been posted.
Premature treatment discontinuation is defined as discontinuation other than due to violent death, natural disaster, or administrative censoring
| proportion of participants | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Proportion Who Prematurely Discontinue Treatment | 0.130 (0.049 to 0.263) | 0.021 (0.001 to 0.111) |
Culture conversion is defined as the first of two negative sputum cultures, consecutive or not, without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs or symptoms of active TB
| weeks | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Median Time to Stable Liquid Culture Conversion by Week 12 | 8 (6 to 10) | 6 (4 to 8) |
Participants rate any change in skin color since TB treatment started on subjective 10-point numeric rating scale where 0=none, 10=worst possible change in coloration.
Results for this outcome have not been posted.
Participants rate distress from change in skin color since TB treatment started on subjective 10-point numeric rating scale where 0=none, 10=worst possible distress due to coloration.
Results for this outcome have not been posted.
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used at each of baseline (screening visit), Week 1, Week 2, Week 4, Week 8, Week 12, and Week 16.
| milliseconds | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Week 1 | 24.8 ± 21.2 | 5.0 ± 22.1 |
| Week 2 | 23.4 ± 21.3 | 5.5 ± 24.5 |
| Week 4 | 30.3 ± 20.8 | 4.0 ± 25.0 |
| Week 8 | 31.9 ± 18.8 | 4.4 ± 28.7 |
| Week 12 | 26.2 ± 23.6 | 7.1 ± 24.8 |
| Week 16 | 25.7 ± 20.7 | 8.8 ± 21.3 |
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used at baseline (screening visit) and week 12 (Arm 1). ECG was not required at week 26 per the protocol thus the week 26 data was not collected.
| milliseconds | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Mean Change in QTcF From Baseline to End of Treatment | 26.2 ± 23.6 | — |
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used through week 16 in Arm 1 and Arm 2
| Participants | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| ≤480 ms | 44 | 48 |
| >480 to ≤500 ms | 1 | 0 |
| >500 ms | 0 | 0 |
The QTcF is derived from ECG readings, which the sites conducted in triplicate (three ECGs 5-10 minutes apart). The mean of all measurements (up to 3) that are readable and available are used at baseline (screening visit) and through week 16 in Arm 1 and Arm 2
| Participants | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| ≤30 ms | 6 | 34 |
| >30 to ≤60 ms | 31 | 11 |
| >60 ms | 8 | 3 |
An SAE is defined as any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but based upon appropriate medical judgment may jeopardize the participant and may require intervention to prevent one of the outcomes listed in the definition above.
Results for this outcome have not been posted.
Proportion of participants who have achieved stable culture conversion, defined as two negative sputum cultures, consecutive or not, without an intervening positive culture and/or visits wherein the participant is unable to produce sputum and has no signs of active TB; occurring before or at the week 4, 8, or 12 visit, respectively.
| proportion of participants | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Week 4 | 0.244 (0.129 to 0.395) | 0.298 (0.173 to 0.449) |
| Week 8 | 0.667 (0.510 to 0.800) | 0.809 (0.667 to 0.909) |
| Week 12 | 0.844 (0.705 to 0.935) | 1.000 (0.925 to 1.000) |
Proportion of participants who have achieved stable culture conversion, defined as two negative sputum cultures, consecutive or not, without an intervening positive culture and/or visits wherein the participant is unable to produce sputum and has no signs of active TB; occurring before or at the week 4, 8, or 12 visit, respectively.
| proportion of participants | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Week 4 | 0.455 (0.304 to 0.612) | 0.591 (0.432 to 0.737) |
| Week 8 | 0.886 (0.754 to 0.962) | 0.955 (0.845 to 0.994) |
| Week 12 | 0.955 (0.845 to 0.994) | 1.000 (0.920 to 1.000) |
For participants who had successful culture conversion through the end of study treatment, TB relapse is defined as a recurrence of TB emanating from the same strain as the participant's originally diagnosed TB, which will be determined through whole genome sequencing.
Results for this outcome have not been posted.
For participants in experimental group only. Minimum Inhibitory Concentration (MIC) values will be evaluated against resistance-associated variants (RAVs) for paired baseline and failure isolates. Frequencies and proportions with phenotypic and/or genotypic resistance to any drug will be reported.
Results for this outcome have not been posted.
Time to positivity in liquid culture is defined as the days required for a sample to exhibit detectable microbial growth (positive result) in liquid media. A shorter time to positivity indicates a higher concentration of viable microorganisms in the original sample. Participants with a negative liquid culture result were imputed to have the 'best' time to positivity of 43 days (\>42 days), and participants with contaminated culture results were excluded. Sputum samples were collected at weeks 1, 2, 3, 4, 6, and 8 for culture in liquid media.
| days | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Week 1 | 11 (9 to 16) | 11 (10 to 15) |
| Week 2 | 14 (11 to 16.5) | 14 (12 to 28) |
| Week 3 | 16.5 (13 to 28) | 18 (15 to 33) |
| Week 4 | 20.5 (14.5 to 43) | 24 (17 to 43) |
| Week 6 | 43 (21 to 43) | 43 (26 to 43) |
| Week 8 | 43 (30 to 43) | 43 (43 to 43) |
Collected over From study entry to study completion, up to 86 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 BCZD | 2/46 (4.3%) | 4/46 (8.7%) | 13/46 (28.3%) |
| Arm 2 RHZE | 0/48 (0%) | 0/48 (0%) | 7/48 (14.6%) |
| Event | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| SepsisInfections and infestations | 1/46 | 0/48 |
| TuberculosisInfections and infestations | 1/46 | 0/48 |
| Femur fractureInjury, poisoning and procedural complications | 1/46 | 0/48 |
| Acute leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/46 | 0/48 |
| DeliriumPsychiatric disorders | 1/46 | 0/48 |
| Event | Arm 1 BCZD | Arm 2 RHZE |
|---|---|---|
| Electrocardiogram QT prolongedInvestigations | 6/46 | 3/48 |
| Alanine aminotransferase increasedInvestigations | 2/46 | 1/48 |
| Haemoglobin decreasedInvestigations | 2/46 | 1/48 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/46 | 2/48 |
| Hypochromic anaemiaBlood and lymphatic system disorders | 1/46 | 0/48 |
| HyperbilirubinaemiaHepatobiliary disorders | 1/46 | 0/48 |
| Neutrophil count decreasedInvestigations | 1/46 | 0/48 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/46 | 0/48 |
| Aspartate aminotransferase increasedInvestigations | 0/46 | 1/48 |
| Age, Continuous(years) | Arm 1 BCZD | Arm 2 RHZE | Total |
|---|---|---|---|
| Median | 33.5 (19 to 65) | 33 (21 to 64) | 33.5 (19 to 65) |
| Sex: Female, Male(Participants) | Arm 1 BCZD | Arm 2 RHZE | Total |
|---|---|---|---|
| Female | 19 | 16 | 35 |
| Male | 27 | 32 | 59 |
| Race and Ethnicity Not Collected(Participants) | Arm 1 BCZD | Arm 2 RHZE | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Arm 1 BCZD | Arm 2 RHZE | Total |
|---|---|---|---|
| Haiti | 20 | 22 | 42 |
| South Africa | 26 | 26 | 52 |
| HIV Status(Participants) | Arm 1 BCZD | Arm 2 RHZE | Total |
|---|---|---|---|
| Negative | 40 | 41 | 81 |
| Positive | 6 | 7 | 13 |
| Cavitation per Chest X-ray for randomization stratification(Participants) | Arm 1 BCZD | Arm 2 RHZE | Total |
|---|---|---|---|
| Absent | 13 | 13 | 26 |
| Present | 33 | 35 | 68 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Where possible, we will make raw data available in publications (directly or through online appendices). Although the final dataset will be stripped of identifiers prior to release for sharing, we believe there remains the possibility of deductive disclosure of subjects with unusual characteristics. We will therefore make the data and associated documentation available to users under a controlled access process/data-sharing agreement, in compliance with current international standards to protect participant confidentiality. Where applicable, data documentation and de-identified data will be deposited for sharing along with demographics consistent with applicable laws and regulations. Data content, format, and organization will conform with relevant data and terminology standards.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Ran from Nov 2023 to primary completion in Jun 2025, 18 months.
Results were first posted in Aug 2026, 1 year 1 month after primary completion.
Of 33 non-industry phase 2 interventional studies under Tuberculosis, Pulmonary, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's 18 months is below that.
Counting every sponsor, half of 43 studies reached it within 30 months; a quarter within 21 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bedaquiline · Clofazimine · OPC-67683
Brigham and Women's Hospital →