Status:
RECRUITING
Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Centre de Recherche en Sante de Nouna, Burkina Faso
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Malnutrition, Child
Severe Acute Malnutrition
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may ...
Detailed Description
General study design. The investigators propose a 1:1:1 individually randomized placebo-controlled trial in which children aged 6-59 months with SAM (based on weight-for-height Z-scores (WHZ) and/or m...
Eligibility Criteria
Inclusion
- Children with uncomplicated SAM per Burkina Faso's national guidelines who present to an eligible enrollment site during the study period and meet all of the eligibility criteria below will be considered for enrollment:
- Inclusion criteria:
- Age 6-59 months
- WHZ\<-3 SD or MUAC\<115 mm
- Primary residence within a catchment area of an enrollment site
- Available for full 8-week study (primary endpoint)
- Not admitted to a nutritional program for SAM treatment in the previous 2 weeks
- No edema
- No antibiotic use in the past 7 days
- No clinical complications requiring antibiotic or 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, etc)
- No known allergies to macrolides/azalides or amoxicillin/penicillin
- Sufficient appetite according to a feeding test with RUTF
- Written informed consent from at least one parent or guardian
- Exclusion criteria:
- Age less than 6 month or more than 59 months
- WHZ\>-3 SD or MUAC\>115 mm
- Primary residence is not within a catchment area of an enrollment site
- Not Available for full 8-week study (primary endpoint)
- Admitted to a nutritional program for SAM treatment in the previous 2 weeks
- Edema
- Antibiotic use in the past 7 days
- Clinical complications requiring antibiotic or 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)
- Known allergies to macrolides/azalides or amoxicillin/penicillin
- No Sufficient appetite according to a feeding test with RUTF
- No Written informed consent from at least one parent or guardian
- Per Burkinabé guidelines, children any of the following conditions will not be eligible for the trial and will be referred to an inpatient facility: MUAC \<115 mm with complications; MUAC \<115 mm plus edema; bipedal pitting edema; anorexia or no appetite for RUTF; diarrhea and dehydration; unable to ingest anything without vomiting; severe pneumonia; open cutaneous lesions; hypothermia (35\*C); fever (38.5\*C); paleness suggesting severe anemia; hypoglycemia; very weak, lethargic, or unconscious; convulsions; signs of vitamin A deficiency; or a condition requiring IV infusion or an NG tube.
Exclusion
Key Trial Info
Start Date :
October 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2028
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06010719
Start Date
October 23 2024
End Date
December 29 2028
Last Update
October 15 2025
Active Locations (1)
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1
Centre de recherche en Santé de nouna
Nouna, Kossi, Burkina Faso