A Phase 3 interventional study of Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline) and Moxifloxacin in MDR-TB, sponsored by IUATLD, Inc. Completed at 13 sites in 7 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by IUATLD, Inc · Phase 3, Interventional, and Treatment
Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
The STREAM study is an international, multi-centre, parallel-group, open-label, randomised, controlled trial in patients with multi-drug resistant tuberculosis (MDR-TB) including patients with rifampicin-resistant and isoniazid-sensitive TB.
Background and Rationale:
In 2011, World Health Organisation (WHO) guidelines for the treatment for MDR-TB recommended an intensive phase of treatment based on at least four drugs known to be effective and given for a minimum of 20 months; this is referred to as the WHO 2011 long regimen. Outcomes with this approach are generally poor. In the most recent WHO TB surveillance report only 50% of MDR-TB patients were successfully treated and a recent meta-analysis reported on average 62% successful outcome and a mortality of 11%.
In 2010, Van Deun et al (2010) reported excellent long-term outcomes in a cohort of over 200 patients in Bangladesh with MDR-TB who were treated with a regimen given for only nine to 11 months. Such a regimen, if successful, would represent a considerable advance over current practice. Evaluation of this regimen is the objective of Stage 1 of STREAM.
In 2016, following review of the available data, the WHO MDR TB treatment guidelines were modified to recommend a 9-12 month shortened regimen under specific conditions similar to Regimen B used in STREAM Stage 1 (referred to as the WHO 2016 short regimen).
Bedaquiline is a novel diarylquinoline antibiotic with bactericidal activity. In a phase II trial of patients with MDR-TB time to culture conversion was significantly less in patients receiving bedaquiline compared to those receiving an optimised background regimen only (Diacon et al (2012). In December 2012 the US Food and Drug Administration (FDA) approved bedaquiline as part of the treatment regimen for MDR-TB when other agents are unavailable. Stage 2 of STREAM was designed to investigate ways in which Regimen B could be improved either by removing the second-line injectable, which is associated with severe drug toxicity, or by shortening the regimen to 6 months.
Treatments that are evaluated within the STREAM trial include:
Regimen A The locally-used MDR-TB regimen in accordance with 2011 WHO MDR-TB treatment guidelines.
Regimen B is based on the regimen described by Van Deun 2010. At the start of STREAM this consisted of clofazimine, ethambutol, moxifloxacin, and pyrazinamide given for 40 weeks, supplemented by isoniazid, kanamycin, and prothionamide in the first 16 weeks (intensive phase). ); this combination is referred to as Regimen Bmox. With Version 8.0 of the protocol Regimen B is modified by replacement of moxifloxacin with levofloxacin (referred to as Regimen Blev). Regimen B without specification of which fluoroquinolone is in the regimen refers to either (Bmox or Blev).
Regimen C is a 40-week all-oral regimen consisting of bedaquiline, clofazimine, ethambutol, levofloxacin, and pyrazinamide given for 40 weeks supplemented by isoniazid and prothionamide for the first 16 weeks (intensive phase).
Regimen D is a 28-week regimen consisting of bedaquiline, clofazimine, levofloxacin, and pyrazinamide given for 28 weeks supplemented by isoniazid and kanamycin for the first 8 weeks (intensive phase).
The primary objectives of the STREAM2 trial are:
To assess whether the proportion of participants with a favourable efficacy outcome at week 76 on Regimen C is non-inferior to that on Regimen B
Study Population: Stage 2 will aim to randomise at least 200 patients to each of Regimens B and C.
All patients will be followed up to Week 132. The primary analysis will be based on the data accrued to Week 76 and is based on the proportion of patients with a favourable outcome at that time point ; the data accrued to Week 132 will be used in secondary analyses.
Although the STREAM study is an open-label study, wherever possible it will be conducted masked to treatment allocation.
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's enrollment of 588 is above the median of 194 across 88 interventional studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →This is the only study on the registry with IUATLD, Inc as lead sponsor.
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.
Exclusion Criteria:
Has a or QTcF interval at screening or immediately prior to randomisation of more than or equal to 500 ms for Stage 1, and more than or equal to 450 ms for Stage 2
In addition to the criteria above, for Stage 2 only, a patient will not be eligible for randomisation to the study if he/she:
Has experienced one or more of the following risk factors for QT prolongation:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Regimen A locally-used WHO-approved MDR-TB regimen in accordance with 2011 WHO MDR-TB treatment guidelines.
Drug: Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline)
Regimen B is based on the regimen described by Van Deun 2010. With Version 8.0 of the protocol Regimen B (Regimen Bmox) is modified by replacement of moxifloxacin with levofloxacin (Regimen Blev). Regimen B without specification of which fluoroquinolone is in the regimen refers to either (Bmox or Blev). Product and dose for \[\<33 kg, 33-50kg, \>50 kg\] respectively: Moxifloxacin \[400mg, 600mg, 800mg\] OR Levofloxacin \[750mg, 750mg,1000mg\]; Clofazimine \[50mg,100mg,100mg\]; Ethambutol \[800mg,800mg,1200mg\]; Pyrazinamide \[1000mg,1500mg, 2000mg\]; Isoniazid 300mg, 400mg, 600mg\]; Prothionamide \[250mg,500mg,750mg\]; Kanamycin \[15mg per kilogram body weight (maximum 1g)\].
Drug: Moxifloxacin · Drug: Clofazimine · Drug: Ethambutol · Drug: Pyrazinamide · Drug: Isoniazid · Drug: Prothionamide · Drug: Kanamycin · Drug: Levofloxacin
Regimen C is a 40-week all-oral regimen consisting of bedaquiline, clofazimine, ethambutol, levofloxacin, and pyrazinamide given for 40 weeks supplemented by isoniazid and prothionamide for the first 16 weeks (intensive phase). Product and dose for \[\<33kg, 33-50kg, \>50 kg\] respectively: Bedaquiline 400mg once daily for first 14 days/200 mg thrice weekly thereafter; Levofloxacin \[750mg, 750mg,1000mg\]; Clofazimine \[50mg, 100mg, 100mg\]; Ethambutol \[800mg, 800mg, 1200mg\]; Pyrazinamide \[1000mg,1500mg, 2000mg\]; Isoniazid \[300mg, 400mg, 600mg\]; Prothionamide \[250mg, 500mg,750mg\].
Drug: Clofazimine · Drug: Ethambutol · Drug: Pyrazinamide · Drug: Isoniazid · Drug: Prothionamide · Drug: Levofloxacin · Drug: Bedaquiline
Regimen D is a 28-week regimen consisting of bedaquiline, clofazimine, levofloxacin, and pyrazinamide given for 28 weeks supplemented by isoniazid and kanamycin for the first 8 weeks (intensive phase). Product and dose for \[\<33kg, 33 to\<40kg, 40-50kg, \>50-60 kg, \>60 kg\] respectively: Bedaquiline 400mg once daily for first 14 days/200mg thrice weekly thereafter; Levofloxacin \[750mg, 750mg, 750mg, 1000mg, 1000mg\]; Clofazimine \[50mg, 100mg, 100mg, 100mg, 100mg\]; Pyrazinamide \[1000mg,1500mg, 1500mg, 2000mg, 2000mg\]; Isoniazid \[400mg, 500mg, 600mg, 800mg, 900mg\]; Kanamycin \[15 mg per kilogram body weight (maximum 1g)\].
Drug: Clofazimine · Drug: Pyrazinamide · Drug: Isoniazid · Drug: Kanamycin · Drug: Levofloxacin · Drug: Bedaquiline
Drug: Locally-used WHO-approved MDR-TB regimen
Moxifloxacin is an 8-methoxy quinolone, and an anti-bacterial fluoroquinolone
Also known as: Avelox
Clofazimine, is an antileprosy and anti-bacterial agent. Its chemical name is 3-(p-chloroanilino)-10-(p-chlorophenyl)-2, 10-dihydro-2-isopropyliminophenazine.
Also known as: Lamprene
Ethambutol is a bacteriostatic that acts against virtually all strains of Mycobacterium tuberculosis and M. bovis and is also active against other mycobacteria such as M. Kansasii.
Also known as: Myambutol
Pyrazinamide is bactericidal against intracellular mycobacterium tuberculosis. It is a prodrug that is converted into its active form, pyrazinoic acid, by a mycobacterial enzyme, pyrazinamidase, as well as through hepatic metabolism.
Also known as: Zinamide
Isoniazid is a bactericidal in vitro and in vivo against actively dividing tubercle bacilli. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique constituents of mycobacterial cell wall.
Also known as: Nydrazid, Isotamine
Prothionamide has a bacteriostatic action.
Also known as: Peteha
Kanamycin is a bactericidal antibiotic from the group of aminoglycosides.
Also known as: Kantrex
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class that acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.
Also known as: Levaquin
Bedaquiline is a novel diarylquinoline antibiotic with bactericidal activity
Also known as: SIRTURO
STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76)
The primary efficacy outcome of the STREAM Stage 2 comparison is status at Week 76 i.e. the proportion of patients with a favourable outcome at Week 76
Time frame: 76 weeks
Favourable Outcome After Long-term Follow-up (132 Weeks)
The proportion of patients with a favourable outcome at their last efficacy visit
Time frame: Last efficacy visit, between 96 and 132 weeks
Proportion of Patients With Acquired Drug Resistance
The proportion of patients with acquired drug resistance (any drug)
Time frame: 132 weeks
Failure or Recurrence (FoR)
probable or definite failure or recurrence (FoR)
Time frame: final efficacy week (between 96 and 132 weeks)
Failure or Recurrence (FoR)
The proportion of patients with failure or recurrence (FoR)
Time frame: 132 weeks, control regimen (arm B) using concurrent controls only
Participants were assessed for eligibility from 13 hospital clinics in seven countries, and were randomised between March 2016 and January 2020
| Milestone | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| Started | 32 | 202 | 211 | 143 |
| Completed | 0 | 187 | 196 | 134 |
| Not completed | 32 | 15 | 15 | 9 |
| Withdrew: Protocol violation | 3 | 6 | 9 | 4 |
| Withdrew: No positive culture/no baseline sample | 3 | 9 | 6 | 5 |
| Withdrew: Completed but not analysed as recruitment stopped to this arm | 26 | 0 | 0 | 0 |
The primary efficacy outcome of the STREAM Stage 2 comparison is status at Week 76 i.e. the proportion of patients with a favourable outcome at Week 76
| Participants | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) | 0 | 133 | 162 | 122 |
The proportion of patients with a favourable outcome at their last efficacy visit
| Participants | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| Favourable Outcome After Long-term Follow-up (132 Weeks) | 17 | 126 | 152 | 115 |
The proportion of patients with acquired drug resistance (any drug)
| Participants | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| Proportion of Patients With Acquired Drug Resistance | 0 | 5 | 5 | 3 |
probable or definite failure or recurrence (FoR)
| Participants | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| Failure or Recurrence (FoR) | 0 | 17 | 4 | 0 |
The proportion of patients with failure or recurrence (FoR)
| Participants | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| Failure or Recurrence (FoR) | — | 14 | — | 2 |
Collected over 132 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regimen A (Long Regimen) | 0/32 (0%) | 8/32 (25%) | 21/32 (65.6%) |
| Regimen B (Control Regimen) | 8/202 (4%) | 44/202 (21.8%) | 114/202 (56.4%) |
| Regimen C (Oral Regimen) | 11/211 (5.2%) | 44/211 (20.9%) | 109/211 (51.7%) |
| Regimen D (6-month Regimen) | 2/143 (1.4%) | 33/143 (23.1%) | 82/143 (57.3%) |
| Event | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| Gastrointestinal disordersGastrointestinal disorders | 2/32 | 1/202 | 5/211 | 1/143 |
| Psychiatric disordersPsychiatric disorders | 2/32 | 1/202 | 0/211 | 0/143 |
| Infections and infestationsInfections and infestations | 0/32 | 12/202 | 9/211 | 3/143 |
| Hearing and vestibular disorders (SMQ)Ear and labyrinth disorders | 0/32 | 7/202 | 7/211 | 7/143 |
| General disorders and administration site conditionsGeneral disorders | 1/32 | 6/202 | 2/211 | 6/143 |
| InvestigationsInvestigations | 1/32 | 3/202 | 4/211 | 5/143 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 0/32 | 7/202 | 5/211 | 2/143 |
| Hepatic disorders (SMQ)Hepatobiliary disorders | 1/32 | 5/202 | 4/211 | 1/143 |
| Pregnancy, puerperium and perinatal conditionsPregnancy, puerperium and perinatal conditions | 1/32 | 1/202 | 3/211 | 3/143 |
| Social circumstancesSocial circumstances | 1/32 | 1/202 | 2/211 | 1/143 |
| Event | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) |
|---|---|---|---|---|
| Metabolism and nutrition disordersMetabolism and nutrition disorders | 10/32 | 22/202 | 30/211 | 20/143 |
| InvestigationsInvestigations | 10/32 | 25/202 | 19/211 | 14/143 |
| Torsade de pointes/QT prolongation (SMQ)Cardiac disorders | 2/32 | 47/202 | 52/211 | 38/143 |
| Hepatic disorders (SMQ)Hepatobiliary disorders | 3/32 | 31/202 | 33/211 | 15/143 |
| Hearing and vestibular disorders (SMQ)Ear and labyrinth disorders | 2/32 | 20/202 | 9/211 | 6/143 |
| Gastrointestinal disordersGastrointestinal disorders | 3/32 | 2/202 | 4/211 | 3/143 |
| Psychiatric disordersPsychiatric disorders | 3/32 | 1/202 | 0/211 | 0/143 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 2/32 | 2/202 | 0/211 | 1/143 |
| General disorders and administration site conditionsGeneral disorders | 0/32 | 5/202 | 4/211 | 6/143 |
| Blood and lymphatic system disordersBlood and lymphatic system disorders | 0/32 | 4/202 | 3/211 | 6/143 |
| Age, Continuous(years) | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) | Total |
|---|---|---|---|---|---|
| Median | 37.0 (26.0 to 42.0) | 32.8 (25.7 to 40.6) | 32.8 (26.9 to 42.8) | 30.8 (25.5 to 41.6) | 32.7 (26. to 42.1) |
| Sex: Female, Male(Participants) | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) | Total |
|---|---|---|---|---|---|
| Female | 17 | 81 | 79 | 59 | 236 |
| Male | 15 | 121 | 132 | 84 | 352 |
| Race and Ethnicity Not Collected(Participants) | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Regimen A (Long Regimen) | Regimen B (Control Regimen) | Regimen C (Oral Regimen) | Regimen D (6-month Regimen) | Total |
|---|---|---|---|---|---|
| Mongolia | 11 | 46 | 48 | 25 | 130 |
| South Africa | 6 | 28 | 32 | 26 | 92 |
| Uganda | 0 | 22 | 25 | 9 | 56 |
| Moldova | 4 | 25 | 26 | 8 | 63 |
| Georgia | 0 | 13 | 12 | 7 | 32 |
| Ethiopia | 6 | 21 | 20 | 20 | 67 |
| India | 5 | 47 | 48 | 48 | 148 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data collected for the study, including individual participant data and a data dictionary defining each field in the set, will be made available no later than 12 months after the end of the trial through the TBPACT data repository.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: From May 2024 at the latest.
Access criteria: Application to CPATH as described on the website.
Data sharing details ↗ · c-path.org
Ran from Mar 2016 to primary completion in May 2022, 74 months.
Results were first posted in Sep 2023, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Clofazimine · Ethambutol · Pyrazinamide · Isoniazid · Kanamycin · Levofloxacin · Bedaquiline
Tuberculosis, Multidrug-Resistant →