SAM: Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
Study Details
Study Description
Brief Summary
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Azithromycin children in this arm will receive one dose of azithromycin |
Drug: Azithromycin
Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Other Names:
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| Active Comparator: Amoxicillin Children in this arm will receive a 7 day course of amoxicillin (standard of care) |
Drug: Amoxicillin
Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
|
Outcome Measures
Primary Outcome Measures
- Weight gain [8 weeks]
Weight will be measured at all follow-up time points and weight gain will be defined as grams per kilogram per day (g/kg/day).
Secondary Outcome Measures
- Nutritional recovery [8 weeks]
Nutritional recovery is defined as, depending on admission criteria: weight-for-height/length ≥ -2 Z-score and the child have had no oedema for at least 2 weeks, or the mid-upper-arm circumference is ≥125 mm and the child have had no oedema for at least 2 weeks.
- Time to recovery [8 weeks]
Time from enrollment to nutritional recovery (defined above) will be recorded.
- Malaria [8 weeks]
Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.
- Mortality [8 weeks]
Vital status will be assessed at all follow-up time points and mortality will be defined as death during the study period.
- Adverse events [8 weeks]
Adverse events will be reported at all follow-up time points
- HAZ [8 weeks]
Height or length will be measured at all follow-up time points and height-for-age z-scores will be calculated.
- MUAC [8 weeks]
Mid-upper arm circumference will be measured at all follow-up time points.
- WAZ [8 weeks]
Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated.
- WHZ [8 weeks]
Weight and height, assessed at all follow-up time points, will be used to calculate weight-for-height z-scores.
- Intestinal microbiome [8 weeks]
baseline and 8 week intestinal microbiome will be compared between the 2 arms
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 6-59 months
-
WHZ <-3 SD or MUAC <115 mm
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No nutritional edema
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Able and willing to participate in full 8-week study
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Has not been admitted to a nutritional program for the treatment of SAM in the 3 preceeding months
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No antibiotic use in past 7 days
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No clinical complications requiring inpatient treatment (except for routine admission for children <6 months)
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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)
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No allergy to macrolides/azalides
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Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
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Appropriate consent from at least one parent or guardian
Exclusion Criteria:
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Age <6 months or >59 months
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WHZ ≥-3 SD or MUAC ≥115 mm
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Nutritional edema
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Not able or willing to participate in full 8-week study
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Admission to a nutritional program for the treatment of SAM in the 3 preceeding months
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Antibiotic use in past 7 days
-
Clinical complications requiring 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)
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Allergy to macrolides/azalides
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Insufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
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Parent or guardian refuses to provide consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de Recherche en santé de nouna | Nouna | Boucle Du Mouhoun | Burkina Faso |
Sponsors and Collaborators
- University of California, San Francisco
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Catherine E Oldenburg, ScD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-25274
- 1R21HD100932-01A1