Using azithromycin to treat severe acute malnutrition in children
Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition: the AMOUR Trial
This study is testing if adding azithromycin to the usual treatment can help young children with severe malnutrition gain weight and improve their health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Nouna, Kossi) |
| Trial ID | NCT06010719 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-59 months diagnosed with uncomplicated severe acute malnutrition.
Not a fit: Patients with clinical complications requiring inpatient treatment or those with chronic debilitating illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery rates and reduce mortality in children suffering from severe acute malnutrition.
How similar studies have performed: Previous studies have shown mixed results with antibiotics for SAM, indicating that while some approaches have been tested, the use of azithromycin in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nouna, Kossi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.