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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT05473234
Eligibility Criteria:
Inclusion criteria (all must be met):
* Age 6-59 months
* Weight-for-height z-score (WHZ) \< -3 SD or mid-upper arm circumference (MUAC) \< 115 mm
* No nutritional or nutritional edema Grade I and II
* Primary residence within catchment area of enrollment site
* Available for full 8-week study
* Has not been admitted to a nutritional program for the treatment of severe acute malnutrition (SAM) in the 2 preceding weeks
* No antibiotic use in past 7 days
* No clinical complications requiring antibiotic treatment
* No clinical complications requiring inpatient treatment
* No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, sickle cell disease, etc)
* No allergy to macrolides/azalides
* Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
* Appropriate written informed consent from at least one parent or guardian
Exclusion criteria (any excludes):
* Age \< 6 months or \> 59 months
* WHZ ≥ -3 SD or MUAC ≥ 115 mm
* Primary residence outside catchment area of enrollment site
* Not available for full 8-week study
* Presence of nutritional edema Grade III
* Admission to a nutritional program for the treatment of SAM in the 2 preceding weeks
* Antibiotic use in past 7 days
* Clinical complications requiring antibiotic treatment
* Clinical complications requiring inpatient treatment
* Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
* Allergy to macrolides/azalides
* Insufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
* Parent or guardian refuses to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT05473234
Study Brief:
Protocol Section:
NCT05473234