CompletedPhase 1/2

Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV

Haiti, South Africa54 participantsStarted 2017-09-21

Plain-language summary

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.

Who can participate

Age range0 Months – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Parent/legal guardian willing and able to provide written informed consent for study participation; in addition, when applicable per local Institutional Review Board (IRB)/Ethics Committee (EC) policies and procedures, potential participant is willing and able to provide written assent for study participation. * Age at enrollment: * Cohort 1: 6 years of age or older but younger than 18 years of age * Cohort 2: 2 years of age or older but younger than 6 years of age * Cohort 3: 0 months of age or older but younger than 2 years of age * Weight at enrollment: * Cohort 1: At least 15 kg * Cohort 2: Greater than 7 kg * Cohort 3: At least 3 kg * HIV status determined by testing requirements in the protocol. * Either bacteriologically confirmed intrathoracic (pulmonary) RR-TB and/or any of the following forms of extrathoracic TB: * Peripheral TB lymphadenitis * Pleural effusion or fibrotic pleural lesions * Stage 1 TBM or clinically stable Stage 2A TBM\* * Osteoarticular TB, including spinal TB * Other non-disseminated forms of TB disease OR Probable RR-TB (or clinically diagnosed RR-TB) with the inclusion of intrathoracic and/or extrathoracic TB as listed below: * A presumptive diagnosis of RR-TB based on well-documented clinical symptoms or signs of TB with chest radiological changes (in the case of intrathoracic TB), and/or any of the following extrathoracic disease manifestations: * Peripheral TB lymphadenitis * Pleural effusion …

What they're measuring

Percentage of Participants With Adverse Events of ≥ Grade 3 Severity

Timeframe: 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

Timeframe: Measured from entry through Week 24

Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event

Timeframe: Measured from entry through Week 24

Percentage of Participants Who Died

Timeframe: Measured from entry through Week 24

Percentage of Participants With Unstable Dysrhythmias Requiring Hospitalization and Treatment

Timeframe: Measured from entry through Week 24

Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT02906007

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-02-07

Results submitted2025-02-06

View on ClinicalTrials.gov More Tuberculosis trials

Plain-language summary

Who can participate

Age range0 Months – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants With Adverse Events of ≥ Grade 3 Severity

Timeframe: 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

Timeframe: Measured from entry through Week 24

Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event

Timeframe: Measured from entry through Week 24

Percentage of Participants Who Died

Timeframe: Measured from entry through Week 24

Percentage of Participants With Unstable Dysrhythmias Requiring Hospitalization and Treatment

Timeframe: Measured from entry through Week 24

Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec

Timeframe: 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

Timeframe: 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.