Using azithromycin to treat severe acute malnutrition in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of azithromycin as an adjunctive treatment for children aged 6-59 months with uncomplicated severe acute malnutrition (SAM). Participants will be randomly assigned to receive either azithromycin, amoxicillin, or a placebo, alongside standard nutritional support. The primary outcome will be measured by weight gain over an 8-week period, with follow-ups to assess relapse and overall health. The study is set in Boromo District, Burkina Faso, a region significantly affected by malnutrition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre de recherche en Santé de nouna
  Nouna, Kossi, Burkina Faso Recruiting

Study contacts

• Principal investigator: Catherine Oldenburg, ScD — University of California, San Francisco
• Study coordinator: Catherine Oldenburg, ScD
• Email: catherine.oldenburg@ucsf.edu
• Phone: 4154761442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.