Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT04972903
Eligibility Criteria:
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 planned PK day
* Signed informed consent from parents or guardian
* Gr4. HIV-negative 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-negative
* 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
NON INCLUSION CRITERIA:
* Very ill or moribund children unable to take drugs orally or requiring nasogastric drug intake
* Severe anaemia (Hb \< 6 g/dl),
* Severe renal impairment (DAIDS grade 3 and above)
* Severe hepatic impairment (DAIDS grade 3 and above)
* Children on second line TB drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
5 Years
Study:
NCT04972903
Study Brief:
Protocol Section:
NCT04972903