Impact of Malnutrition on Pharmacokinetic of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol i… (NCT04972903) | Clinical Trial Compass
CompletedNot Applicable
Impact of Malnutrition on Pharmacokinetic of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in TB-HIV Co-infected Children (TB-Speed TB-PK)
Uganda, Zambia85 participantsStarted 2021-11-08
Plain-language summary
TB-Speed TB-PK is a cross-sectional PK study of anti-TB treatment nested in the TB-Speed HIV and TB-Speed SAM studies aiming at assessing the impact of malnutrition on PK of rifampicin, isoniazid, pyrazinamide, and ethambutol in TB-HIV co-infected children in Uganda and Zambia.
Who can participate
Age range
6 Months – 5 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:
* Gr1. HIV-infected children with SAM
* Age 6 months to 5 years
* Diagnosed with TB and first line TB treatment to be initiated or started less than 4 weeks prior to inclusion
* HIV-infection
* SAM as defined by WHO at the time of starting TB treatment
* Weight-for-height z-score (WHZ) \< -3 SD,
* OR MUAC \<11.5 cm or
* OR presence of bilateral pitting oedema of nutritional origin
* Ability to take drugs orally during the planned PK day
* Signed informed consent from parents or guardian
* Gr2. HIV-infected children without SAM
* Age 6 months to 5 years
* Diagnosed with TB and first line TB treatment to be initiated or started less than 4 weeks prior to inclusion
* HIV-infection
* Absence of SAM as defined by WHO at the time of starting TB treatment
* Weight-for-height z-score (WHZ) \> -3 SD,
* AND MUAC \>11.5 cm or
* AND absence of bilateral pitting oedema of nutritional origin
* Ability to take drugs orally during the planned PK day
* Signed informed consent from parents or guardian
* Gr3. HIV-negative children with SAM
* Age 6 months to 5 years
* Diagnosed with TB and first line TB treatment to be initiated or started less than 4 weeks prior to inclusion
* HIV-negative
* SAM as defined by WHO at the time of starting TB treatment
* Weight-for-height z-score (WHZ) \< -3 SD,
* OR MUAC \<11.5 cm or
* OR presence of bilateral pitting oedema of nutritional origin
* Ability to take drugs orally during the …
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
Effect of SAM on Peak plasma concentration of rifampicin, isoniazid, pyrazinamide, and ethambutol in children with TB
Timeframe: 6 months
2
Effect of SAM on minimum plasma concentration of rifampicin, isoniazid, pyrazinamide, and ethambutol in children with TB
Timeframe: 6 months
3
Effect of SAM on Area Under the Curve plasma concentration of rifampicin, isoniazid, pyrazinamide, and ethambutol in children with TB
Timeframe: 6 months
Trial details
NCT IDNCT04972903
SponsorInstitut National de la Santé Et de la Recherche Médicale, France