Could a single dose of azithromycin save more malnourished kids?
NCT ID NCT06010719
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a single dose of azithromycin helps children aged 6-59 months with severe acute malnutrition gain weight better than the standard 7-day amoxicillin course or a placebo. Researchers will enroll 3,000 children in Burkina Faso and track weight gain and nutritional recovery over 8 weeks. The goal is to find a more effective antibiotic to reduce deaths in this vulnerable group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- azithromycin
- What this could lead to
- If it works, this could offer a simpler, more effective antibiotic option to help malnourished children recover and reduce mortality.
- What could go wrong
- This is a Phase 4 trial, but previous studies on antibiotics for malnutrition have had conflicting results, so azithromycin may not prove better than current care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 59 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre de recherche en Santé de nouna
RECRUITINGNouna, Kossi, Burkina Faso
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- Can a better diet during malnutrition recovery rewire a Child's brain?
- New nutrition pathway aims to spot malnourished kids sooner in hospitals