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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03568643
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 3
Start date June 3, 2020
Completion date December 25, 2020

See also
  Status Clinical Trial Phase
Completed NCT01705769 - Effects of Three Feeding Regimens on Recovery of Uncomplicated Severely Acute Malnourished Children N/A