Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

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.

Timeline

Start

2020-06-03

Primary completion

2020-12-25

Completion

2020-12-25

Publications

• Oldenburg CE, Hinterwirth A, Dah C, Millogo O, Coulibaly B, Ouedraogo M, Sie A, Chen C, Zhong L, Ruder K, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Microbiome among Children with Uncomplicated Severe Acute Malnutrition in a Randomized Controlled Trial of Azithromycin versus Amoxicillin. Am J Trop Med Hyg. 2022 Dec 12;108(1):206-211. doi: 10.4269/ajtmh.22-0381. Print 2023 Jan 11.
• Oldenburg CE, Hinterwirth A, Ourohire M, Dah C, Ouedraogo M, Sie A, Boudo V, Chen C, Ruder K, Zhong L, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Resistome after Antibiotics among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2022 Jun 13;107(1):59-64. doi: 10.4269/ajtmh.22-0007. Print 2022 Jul 13.
• Sie A, Dah C, Ourohire M, Ouedraogo M, Boudo V, Arzika AM, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Oldenburg CE. Azithromycin versus Amoxicillin and Malarial Parasitemia among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2021 Sep 27;106(1):351-355. doi: 10.4269/ajtmh.21-0595.
• O'Brien KS, Sie A, Dah C, Ourohire M, Arzika AM, Boudo V, Lebas E, Godwin WW, Arnold BF, Oldenburg CE. Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):97. doi: 10.1186/s40814-021-00836-w.

Drugs

Indications

No indication recorded.