Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, an… (NCT02906007) | Clinical Trial Compass
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 range
0 Months – 17 Years
Sex
ALL
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Adverse Events of ≥ Grade 3 Severity
Timeframe: Measured from entry through Week 24
2
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
3
Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event
Timeframe: Measured from entry through Week 24
4
Percentage of Participants Who Died
Timeframe: Measured from entry through Week 24
5
Percentage of Participants With Unstable Dysrhythmias Requiring Hospitalization and Treatment
Timeframe: Measured from entry through Week 24
6
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.
7
Trial details
NCT IDNCT02906007
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
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.