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Could a single dose of azithromycin save more malnourished kids?

NCT ID NCT06010719

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

6 to 59 months

Sex

Anyone

Healthy volunteers

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

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.

Child Nutrition Disorders nutritional deficiency disease protein-energy malnutrition Severe Acute Malnutrition

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centre de recherche en Santé de nouna

    RECRUITING

    Nouna, Kossi, Burkina Faso

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