A Phase 1/2 interventional study of Bedaquiline in Tuberculosis and HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 4 sites in 2 countries. Open to participants aged 0 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed rifampin-resistant tuberculosis (RR-TB). The study was designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks.
The purpose of this study was to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in combination with an individualized RR-TB therapy in infants, children, and adolescents with RR-TB disease, living with or without HIV.
This study was conducted among infants, children, and adolescents less than 18 years of age treated for clinically diagnosed or bacteriologically confirmed intra-thoracic (pulmonary) RR-TB and/or selected forms of extrathoracic RR-TB. Participants were assigned to cohorts based on age. Cohort 1 included children six years of age or older but less than 18 years of age; Cohort 2 included children two years of age or older but less than six years of age; and Cohort 3 included children 0 months of age and older but less than two years of age. Cohort 1 was divided into two weight bands, one for participants weighing 15 kg or more but less than 30 kg and one for participants weighing 30 kg or more. Cohort 2 included participants weighing greater than 7 kg. Cohort 3 included participants weighing at least 3 kg.
Study visits occurred at enrollment (Day 0) and at Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 60, 72, and 96. Participants who exited the study before implementation of protocol Version 2.0 also had a study visit at Week 120. Participants in each cohort took BDQ once a day for approximately two weeks. For the next 22 weeks, BDQ was taken three times a week. Dosing for Cohorts 2 and 3 was based on data from Cohort 1.
Study visits included physical examinations, blood and urine collection, an electrocardiogram (ECG), medical history reviews, and other assessments.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 54 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) 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.
Age at enrollment:
Weight at enrollment:
Either bacteriologically confirmed intrathoracic (pulmonary) RR-TB and/or any of the following forms of extrathoracic TB:
Probable RR-TB (or clinically diagnosed RR-TB) with the inclusion of intrathoracic and/or extrathoracic TB as listed below:
More information on this criterion can be found in the protocol.
- Participant is on an RR-TB regimen as per local standard of care for at least seven days and not more than 12 weeks prior to entry, and tolerating the regimen well at entry, as determined by the site investigator based on available medical records.
Note: Participants may have received up to seven doses of non-study BDQ during the seven days prior to study enrollment. The date and dose amount of non-study BDQ doses must be available in medical records.
Exclusion 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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Participants ≥30 kg: 400 mg once per day through the intensive PK sampling visit, then 200 mg three times per week on Monday, Wednesday, and Friday through the Week 24 visit Participants ≥15 to \<30 kg: 200 mg once per day through the intensive PK sampling visit, then 100 mg three times per week on Monday, Wednesday, and Friday through the Week 24
Drug: Bedaquiline
Participants \>7 to \<30 kg: 200 mg once per day through the intensive PK sampling visit, then 100 mg three times per week on Monday, Wednesday, and Friday through the Week 24 visit
Drug: Bedaquiline
Participants \>7 to \<30 kg: 200 mg once per day through the intensive PK sampling visit, then 100 mg three times per week on Monday, Wednesday, and Friday through the Week 24 visit Participants ≥ 3 to ≤ 7 kg: 100 mg once per day through the intensive PK sampling visit, then 50 mg three times per week on Monday, Wednesday, and Friday through the Week 24 visit
Drug: Bedaquiline
Participants received bedaquiline (BDQ) once per day through intensive PK sampling visit, then 3 times per week on Monday, Wednesday and Friday through the week 24 visit.
Also known as: BDQ
Percentage of Participants With Adverse Events of ≥ Grade 3 Severity
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
Time frame: Measured from entry through Week 24
Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1.
Time frame: Measured from entry through Week 24
Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1.
Time frame: Measured from entry through Week 24
Percentage of Participants Who Died
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.0.
Time frame: Measured from entry through Week 24
Percentage of Participants With Unstable Dysrhythmias Requiring Hospitalization and Treatment
At entry and follow-up, any participant who experienced unstable dysrhythmias that required hospitalization and treatment were considered as an adverse event. The core team reviewed and confirmed the sites assessment of event relatedness to study drug.
Time frame: Measured from entry through Week 24
Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec
Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were included if they had QTcF ≥ 500 msec at any study visit from entry to Week 24.
Time frame: All participants had ECG performed at Screening and Entry visits and through week 24.
Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h or AUC0-168h) Bedaquiline
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The final population PK model was developed using a nonlinear mixed effects model (NNMEM, version 7.5). * Developed a population PK model as part of the final PK analysis * Data used in the population PK analysis included the intensive PK visit (Week 1 or Week 2), sparse PK samples from Weeks 4, 8, 12, 16, 20, 24, etc,as available at time of final analysis (when all participants have at least Week 24 PK samples) * Estimated individual AUC values at given time points for each participant using the developed model
Time frame: Intensive PK Week 1 or 2, Week 8, and Week 24, (if intensive then pre dose, and post dose at 2, 4, 6, 8 hours) and if not intensive then predose only.
Percentage of Participants With Adverse Events ≥ Grade 3 Severity
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome.
Time frame: Measured from entry through study completion, up to 120 weeks
Percentage of Participants With Adverse Events ≥ Grade 3 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug.
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome.
Time frame: Measured from entry through study completion, up to 120 weeks
Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec
Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were included if they had QTcF ≥ 500 msec at any study visit from entry to Week 40.
Time frame: Measured from entry through study week 40
Percentage of Participants With Unstable Dysrhythmias Requiring Hospitalization and Treatment
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcomes.
Time frame: Measured from entry through study completion, up to 120 weeks
Percentage of Participants Who Died
At entry and follow-up, death of all causes
Time frame: Measured from entry through study completion, up to 120 weeks
Percentage of Participants With TB Treatment Outcomes at End of Rifampin Resistant (RR) Treatment Among Those Not Living With HIV
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of RR treatment and end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
Time frame: Measured from entry through end of RR treatment, up to 81 weeks
Percentage of Participants With TB Treatment Outcomes at End of Rifampin Resistant (RR) Treatment Among Those Living With HIV
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of RR treatment and end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
Time frame: Measured from entry through end of RR treatment, up to 81 weeks
Percentage of Participants With TB Treatment Outcomes at End of Study Among Those Not Living With HIV
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
Time frame: Measured from entry through study completion, up to 120 weeks
Percentage of Participants With TB Treatment Outcomes at End of Study Among Those Living With HIV
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
Time frame: Measured from entry through study completion, up to 120 weeks
Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h or AUC0-168h) Bedaquiline Mono-desmethyl Metabolite (M2)
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The final population PK model was developed using a nonlinear mixed effects model (NNMEM, version 7.5). * Developed a population PK model as part of the final PK analysis * Data used in the population PK analysis included the intensive PK visit (Week 1 or Week 2), sparse PK samples from Weeks 4, 8, 12, 16, 20, 24, etc,as available at time of final analysis (when all participants have at least Week 24 PK samples) * Estimated individual AUC values at given time points for each participant using the developed model
Time frame: Intensive PK Week 1 or 2, Week 8, and Week 24, (if intensive then pre dose, and post dose at 2, 4, 6, 8 hours) and if not intensive then predose only.
Geometric Mean of Maximal Concentration (Cmax) Bedaquiline
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The final population PK model was developed using a nonlinear mixed effects model (NNMEM, version 7.5). * Developed a population PK model as part of the final PK analysis * Data used in the population PK analysis included the intensive PK visit (Week 1 or Week 2), sparse PK samples from Weeks 4, 8, 12, 16, 20, 24, etc,as available at time of final analysis (when all participants have at least Week 24 PK samples) * Estimated individual AUC values at given time points for each participant using the developed model
Time frame: Intensive PK Week 1 or 2, Week 8, and Week 24, (if intensive then pre dose, and post dose at 2, 4, 6, 8 hours) and if not intensive then pre dose only.
Geometric Mean of Maximal Concentration (Cmax) Bedaquiline Mono-desmethyl Metabolite (M2)
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Time frame: Intensive PK Week 1 or 2, Week 8, and Week 24, (if intensive then pre dose, and post dose at 2, 4, 6, 8 hours) and if not intensive then pre dose only.
Geometric Mean of Trough Concentration (Ctrough) Bedaquiline
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model. Lowest concentration at end of the dosing interval which is approximately 24h after dose at Intensive PK (Week 1 or 2) and 48-72h at Weeks 8 and 24.
Time frame: Intensive PK (Week 1 or 2) 24h post dose and Weeks 8 and 24 48-72h post dose
Geometric Mean of Trough Concentration (Ctrough) Bedaquiline Mono-desmethyl Metabolite (M2)
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model. Lowest concentration at end of the dosing interval which is approximately 24h after dose at Intensive PK (Week 1 or 2) and 48-72h at Weeks 8 and 24.
Time frame: Intensive PK (Week 1 or 2) 24h post dose and Weeks 8 and 24 48-72h post dose
Median of Time of Maximal Concentration (Tmax) Bedaquiline
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Time frame: Intensive PK (Week 1 or 2) pre-dose and 2, 4, 6, 8 hours post dose
Median of Time of Maximal Concentration (Tmax) Bedaquiline Mono-desmethyl Metabolite (M2)
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Time frame: Intensive PK (Week 1 or 2) pre dose and 2, 4, 6, 8 hours post dose
Geometric Mean of Oral Clearance (CL/F) Bedaquiline
Individual clearance (CL) relative to bioavailability (F) determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
Time frame: Week 24
Geometric Mean of Theoretical Steady State AUC (AUC0-168h)
Calculated PK parameter determined from weekly continuation phase dose divided by oral clearance at week 24
Time frame: Week 24
Median Quantitative Post-treatment Bedaquiline Concentrations
PK assessments were performed to determine plasma concentrations of BDQ at selected time points. All concentrations reported to be below the limit of quantification were imputed to zero in these calculations
Time frame: Weeks 8, 16, 24, 36, 48, 72, and 96 after BDQ discontinuation
Percentage of Participants With Post-treatment Bedaquiline Concentrations Below Limit of Quantifications (BLQ)
PK assessments were performed to determine plasma concentrations of BDQ at selected time points. "
Time frame: Weeks 8, 16, 24, 36, 48, 72, and 96 after BDQ discontinuation
The first enrollment to the study was in September 2017 and enrollment was completed in August 2023 with a total of 54 participants who initiated study drug. There enrollments were from one site in Haiti - Les Centres Gheskio INLR CRS, and three sites from South Africa - Desmond Tutu TB Center - Stellenbosch University, Sizwe CRS, and PHRU Matlosana CRS.
| Milestone | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Started | 18 | 18 | 18 |
| Completed | 17 | 18 | 17 |
| Not completed | 1 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Died | 1 | 0 | 0 |
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Adverse Events of ≥ Grade 3 Severity | 38.9 (17.3 to 64.3) | 11.1 (1.4 to 34.7) | 83.3 (58.6 to 96.4) |
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug | 5.6 (0.1 to 27.3) | 0 (0 to 18.5) | 0 (0 to 18.5) |
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event | 0 (0 to 18.5) | 0 (0 to 18.5) | 0 (0 to 18.5) |
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.0.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants Who Died | 5.6 (0.1 to 27.3) | 0 (0 to 18.5) | 0 (0 to 18.5) |
At entry and follow-up, any participant who experienced unstable dysrhythmias that required hospitalization and treatment were considered as an adverse event. The core team reviewed and confirmed the sites assessment of event relatedness to study drug.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Unstable Dysrhythmias Requiring Hospitalization and Treatment | 0 (0 to 18.5) | 0 (0 to 18.5) | 0 (0 to 18.5) |
Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were included if they had QTcF ≥ 500 msec at any study visit from entry to Week 24.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec | 5.6 (0.1 to 27.3) | 0 (0 to 18.5) | 0 (0 to 18.5) |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The final population PK model was developed using a nonlinear mixed effects model (NNMEM, version 7.5). * Developed a population PK model as part of the final PK analysis * Data used in the population PK analysis included the intensive PK visit (Week 1 or Week 2), sparse PK samples from Weeks 4, 8, 12, 16, 20, 24, etc,as available at time of final analysis (when all participants have at least Week 24 PK samples) * Estimated individual AUC values at given time points for each participant using the developed model
| hour*mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Intensive PK (week 1 or 2) (AUC0-24) | 32.6 ± 59.8 | 56.5 ± 32.7 | 60.3 ± 52.1 |
| Week 8 (AUC0-168h) | 121 ± 51.3 | 179 ± 19.4 | 194 ± 58.3 |
| Week 24 (AUC0-168h) | 125 ± 50.8 | 180 ± 20.3 | 202 ± 51.8 |
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Adverse Events ≥ Grade 3 Severity | 38.8 (17.3 to 64.3) | 33.3 (13.3 to 59.0) | 83.3 (58.6 to 96.4) |
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Adverse Events ≥ Grade 3 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug. | 5.6 (0.1 to 27.3) | 0 (0.0 to 18.5) | 0 (0.0 to 18.5) |
Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were included if they had QTcF ≥ 500 msec at any study visit from entry to Week 40.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec | 5.6 (0.1 to 27.3) | 0 (0.0 to 18.5) | 0 (0.0 to 18.5) |
At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcomes.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants With Unstable Dysrhythmias Requiring Hospitalization and Treatment | 0 (0.0 to 18.5) | 0 (0.0 to 18.5) | 0 (0.0 to 18.5) |
At entry and follow-up, death of all causes
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Percentage of Participants Who Died | 5.6 (0.1 to 27.3) | 0.0 (0.0 to 18.5) | 0.0 (0.0 to 18.5) |
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of RR treatment and end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Bacteriological Cure | 92.3 (64.0 to 99.8) | 29.4 (10.3 to 56.0) | 31.3 (11.0 to 58.7) |
| Probable Cure | 7.7 (0.2 to 36.0) | 70.6 (44.0 to 89.7) | 68.8 (41.3 to 89.0) |
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of RR treatment and end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Bacteriological Cure | 40.0 (5.3 to 85.3) | 0.0 (0.0 to 97.5) | 50.0 (1.3 to 98.7) |
| Probable Cure | 40.0 (5.3 to 85.3) | 100 (2.5 to 100) | 50.0 (1.3 to 98.7) |
| Death | 20.0 (0.5 to 71.6) | 0.0 (0.0 to 97.5) | 0.0 (0.0 to 84.2) |
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Bacteriological Cure | 84.6 (54.6 to 98.1) | 29.4 (10.3 to 56.0) | 31.3 (11.0 to 58.7) |
| Probable Cure with no TB recurrence | 7.7 (0.2 to 36.0) | 70.6 (44.0 to 89.7) | 62.5 (35.4 to 84.8) |
| TB recurrence | 7.7 (0.2 to 36.0) | 0.0 (0.0 to 19.5) | 6.3 (0.2 to 30.2) |
TB treatment outcomes were evaluated by team-identified independent endpoint reviewers through end of study. TB Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol.
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Bacteriological Cure | 40.0 (5.3 to 85.3) | 0.0 (0.0 to 97.5) | 50.0 (1.3 to 98.7) |
| Probable Cure with no TB recurrence | 40.0 (5.3 to 85.3) | 100 (2.5 to 100) | 50.0 (1.3 to 98.7) |
| Death | 20.0 (0.5 to 71.6) | 0.0 (0.0 to 97.5) | 0.0 (0.0 to 84.2) |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The final population PK model was developed using a nonlinear mixed effects model (NNMEM, version 7.5). * Developed a population PK model as part of the final PK analysis * Data used in the population PK analysis included the intensive PK visit (Week 1 or Week 2), sparse PK samples from Weeks 4, 8, 12, 16, 20, 24, etc,as available at time of final analysis (when all participants have at least Week 24 PK samples) * Estimated individual AUC values at given time points for each participant using the developed model
| hour*mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Intensive PK (Week 1 or 2) (AUC0-24) | 9.14 ± 30.6 | 11.3 ± 50.2 | 8.63 ± 57.9 |
| Week 8 (AUC0-168h) | 28.4 ± 40.1 | 41.4 ± 32.0 | 33.0 ± 56.6 |
| Week 24 (AUC0-168h) | 32.6 ± 39.6 | 45.0 ± 29.5 | 39.3 ± 48.3 |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The final population PK model was developed using a nonlinear mixed effects model (NNMEM, version 7.5). * Developed a population PK model as part of the final PK analysis * Data used in the population PK analysis included the intensive PK visit (Week 1 or Week 2), sparse PK samples from Weeks 4, 8, 12, 16, 20, 24, etc,as available at time of final analysis (when all participants have at least Week 24 PK samples) * Estimated individual AUC values at given time points for each participant using the developed model
| mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Intensive PK (Week 1 or 2) (Cmax) | 2.16 ± 54.2 | 3.72 ± 34.8 | 4.22 ± 43.4 |
| Week 8 (Cmax) | 1.92 ± 34.3 | 2.37 ± 20.5 | 2.73 ± 31.1 |
| Week 24 (Cmax) | 2.01 ± 35.3 | 2.42 ± 19.3 | 2.66 ± 33.6 |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
| mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Intensive PK (Week 1 or 2) (Cmax) | 0.389 ± 30.3 | 0.481 ± 48.9 | 0.369 ± 57.2 |
| Week 8 (Cmax) | 0.180 ± 37.2 | 0.260 ± 32.2 | 0.216 ± 52.6 |
| Week 24 (Cmax) | 0.206 ± 38.2 | 0.282 ± 29.0 | 0.248 ± 44.6 |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model. Lowest concentration at end of the dosing interval which is approximately 24h after dose at Intensive PK (Week 1 or 2) and 48-72h at Weeks 8 and 24.
| mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Intensive PK (Week 1 or 2) | 0.774 ± 75.1 | 1.27 ± 36.7 | 1.07 ± 79.8 |
| Week 8 | 0.356 ± 61.2 | 0.596 ± 23.1 | 0.650 ± 62.5 |
| Week 24 | 0.792 ± 86.2 | 0.949 ± 38.3 | 0.935 ± 60.1 |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model. Lowest concentration at end of the dosing interval which is approximately 24h after dose at Intensive PK (Week 1 or 2) and 48-72h at Weeks 8 and 24.
| mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Intensive PK (Week 1 or 2) | 0.381 ± 31.6 | 0.465 ± 52.1 | 0.351 ± 58.6 |
| Week 8 | 0.160 ± 43.6 | 0.236 ± 33.4 | 0.189 ± 59.0 |
| Week 24 | 0.196 ± 40.3 | 0.270 ± 30.2 | 0.232 ± 46.8 |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
| h | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Median of Time of Maximal Concentration (Tmax) Bedaquiline | 5.91 (3.16 to 6.58) | 5.08 (3.09 to 6.88) | 5.74 (4.03 to 6.98) |
PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
| h | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Median of Time of Maximal Concentration (Tmax) Bedaquiline Mono-desmethyl Metabolite (M2) | 0 (0 to 24.3) | 13.4 (0 to 24.2) | 13.6 (0 to 24.3) |
Individual clearance (CL) relative to bioavailability (F) determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model
| L/h | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Geometric Mean of Oral Clearance (CL/F) Bedaquiline | 3.22 ± 58.0 | 1.45 ± 35.2 | 1.03 ± 62.0 |
Calculated PK parameter determined from weekly continuation phase dose divided by oral clearance at week 24
| hour*mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Geometric Mean of Theoretical Steady State AUC (AUC0-168h) | 140 ± 42.6 | 207 ± 35.2 | 259 ± 68.7 |
PK assessments were performed to determine plasma concentrations of BDQ at selected time points. All concentrations reported to be below the limit of quantification were imputed to zero in these calculations
| mg/L | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Week 8 post BDQ | 0.254 (0.0983 to 1.404) | 0.3435 (0.1878 to 1.295) | 0.5911 (0.08292 to 3.363) |
| Week 16 post BDQ | 0.172 (0.0618 to 0.7774) | 0.2335 (0.123 to 0.515) | 0.376 (0.04411 to 1.068) |
| Week 24 post BDQ | 0.158 (0.0281 to 0.4911) | 0.149 (0.0794 to 0.4932) | 0.1646 (0.02976 to 2.039) |
| Week 36 post BDQ | 0.10375 (0.00656 to 0.3744) | 0.05803 (0.03361 to 0.2044) | 0.1457 (0 to 1.441) |
| Week 48 post BDQ | 0.068255 (0 to 0.166) | 0.03466 (0 to 0.2197) | 0.08087 (0 to 0.4946) |
| Week 72 post BDQ | 0.025 (0 to 0.102) | 0 (0 to 0.05338) | 0.02665 (0 to 0.4403) |
| Week 96 post BDQ | 0 (0 to 0.0689) | 0 (0 to 0.02752) | 0.02778 (0 to 0.3045) |
PK assessments were performed to determine plasma concentrations of BDQ at selected time points. "
| percentage of participants | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) |
|---|---|---|---|
| Week 8 post BDQ | 0 | 0 | 0 |
| Week 16 post BDQ | 0 | 0 | 0 |
| Week 24 post BDQ | 0 | 0 | 0 |
| Week 36 post BDQ | 0 | 0 | 6.666667 |
| Week 48 post BDQ | 18.75 | 18.18182 | 7.142857 |
| Week 72 post BDQ | 43.75 | 66.66667 | 40 |
| Week 96 post BDQ | 69.23077 | 91.66667 | 44.44444 |
Collected over From entry through end of study follow-up with a maximum of 120 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: >= 6 to < 18 Years | 1/18 (5.6%) | 5/18 (27.8%) | 18/18 (100%) |
| Cohort 2: >= 2 to < 6 Years | 0/18 (0%) | 2/18 (11.1%) | 18/18 (100%) |
| Cohort 3: >= 0 to < 2 Years | 0/18 (0%) | 4/18 (22.2%) | 18/18 (100%) |
| Event | Cohort 1: >= 6 to < 18 Years | Cohort 2: >= 2 to < 6 Years | Cohort 3: >= 0 to < 2 Years |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/18 | 1/18 | 0/18 |
| Drug-induced liver injuryHepatobiliary disorders | 1/18 | 0/18 | 0/18 |
| Hepatitis viralInfections and infestations | 0/18 | 0/18 | 1/18 |
| Lower respiratory tract infectionInfections and infestations | 1/18 | 0/18 | 0/18 |
| Otitis media staphylococcalInfections and infestations | 1/18 | 0/18 | 0/18 |
| Tooth abscessInfections and infestations | 0/18 | 0/18 | 1/18 |
| Head injuryInjury, poisoning and procedural complications | 1/18 | 0/18 | 0/18 |
| Radius fractureInjury, poisoning and procedural complications | 1/18 | 0/18 | 0/18 |
| Thermal burnInjury, poisoning and procedural complications | 0/18 | 0/18 | 1/18 |
| Blood bicarbonate decreasedInvestigations | 0/18 | 0/18 | 1/18 |
| Event | Cohort 1: >= 6 to < 18 Years | Cohort 2: >= 2 to < 6 Years | Cohort 3: >= 0 to < 2 Years |
|---|---|---|---|
| Blood bicarbonate decreasedInvestigations | 18/18 | 18/18 | 17/18 |
| Blood sodium decreasedInvestigations | 7/18 | 14/18 | 15/18 |
| Haemoglobin decreasedInvestigations | 9/18 | 15/18 | 9/18 |
| Blood creatinine increasedInvestigations | 9/18 | 12/18 | 11/18 |
| Blood potassium increasedInvestigations | 9/18 | 7/18 | 12/18 |
| Aspartate aminotransferase increasedInvestigations | 9/18 | 11/18 | 7/18 |
| Blood lactic acid abnormalInvestigations | 11/18 | 0/18 | 1/18 |
| Blood calcium increasedInvestigations | 1/18 | 3/18 | 10/18 |
| VomitingGastrointestinal disorders | 8/18 | 4/18 | 2/18 |
| Alanine aminotransferase increasedInvestigations | 8/18 | 7/18 | 4/18 |
| Age, Continuous(years) | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) | Total |
|---|---|---|---|---|
| Median | 12.7 (7.0 to 13.8) | 3.4 (2.8 to 4.4) | 1.2 (0.7 to 1.8) | 3.4 (1.8 to 7.0) |
| Sex: Female, Male(Participants) | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) | Total |
|---|---|---|---|---|
| Female | 12 | 9 | 9 | 30 |
| Male | 6 | 9 | 9 | 24 |
| Race/Ethnicity, Customized(Participants) | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) | Total |
|---|---|---|---|---|
| Black African | 15 | 10 | 15 | 40 |
| Coloured | 3 | 7 | 3 | 13 |
| Mixed | 0 | 1 | 0 | 1 |
| HIV-1 status(Participants) | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) | Total |
|---|---|---|---|---|
| not living with HIV | 13 | 17 | 16 | 46 |
| living with HIV | 5 | 1 | 2 | 8 |
| Weight(kilogram (kg)) | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) | Total |
|---|---|---|---|---|
| Median | 36 (20 to 41) | 13 (11 to 15) | 9 (7 to 10) | 13 (10 to 20) |
| Height(centimeter (cm)) | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) | Total |
|---|---|---|---|---|
| Median | 151 (117 to 159) | 95 (86 to 100) | 74 (68 to 79) | 95 (79 to 117) |
| TB disease spectrum(Participants) | Cohort 1 (≥ 6 to < 18 Years) | Cohort 2 (≥ 2 to < 6 Years) | Cohort 3 (≥ 0 to < 2 Years) | Total |
|---|---|---|---|---|
| Pulmonary TB (PTB) | 15 | 17 | 17 | 49 |
| Extra Pulmonary TB (EPTB) | 1 | 0 | 0 | 1 |
| PTB and EPTB | 2 | 1 | 1 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Feb 2024, 76 months.
Results were first posted in Mar 2025, 1 year 1 month after primary completion.
Of 18 phase 1/2 interventional studies under Tuberculosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 53. This study's 76 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bedaquiline
National Institute of Allergy and Infectious Diseases (NIAID) →