@article {1636, title = {Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial.}, journal = {BMJ Open}, volume = {15}, year = {2025}, month = {2025 Jul 01}, pages = {e104591}, abstract = {

INTRODUCTION: Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1-59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

METHODS AND ANALYSIS: This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6-59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score \<-3 SD and/or mid-upper arm circumference \<115 mm. Additionally, the children must not have received antibiotics in the past 7 days and have not received nutritional programme treatment for SAM in the 2 weeks before enrolling in the study. Each participant will receive a 7-day course of treatment or placebo based on the arm they were randomised to; 1 dose of azithromycin plus placebo for consistency in the number of doses, 7 days of amoxicillin or 7 days of placebo, with the first dose directly observed in all arms. The primary endpoint outcome will be weight gain defined by g/kg/day at 8 weeks. Mortality and relapse will be assessed at 8 weeks and 3 months, 6 months, 9 months and 12 months.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23-39411) and the Comit{\'e} d{\textquoteright}Ethique pour la Recherche en Sant{\'e} in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

TRIAL REGISTRATION NUMBER: NCT06010719.

}, keywords = {Amoxicillin, Anti-Bacterial Agents, Azithromycin, Child, Preschool, Double-Blind Method, Female, Humans, Infant, Male, Randomized Controlled Trials as Topic, Severe Acute Malnutrition}, issn = {2044-6055}, doi = {10.1136/bmjopen-2025-104591}, author = {Bountogo, Mamadou and Zakane, Alphonse and Ouedraogo, Thierry A and Ouermi, Lucienne and Compaor{\'e}, Guillaume and Compaor{\'e}, Adama and Coulibaly, Boubacar and Koueta, Fla and Burroughs, Hadley R and Fetterman, Ian and La Mons, Jessica L and Lebas, Elodie and Doan, Thuy and Hsiang, Michelle and O{\textquoteright}Brien, Kieran Sunanda and Arnold, Benjamin and Sie, Ali and Oldenburg, Catherine E} } @article {161, title = {Gut Bacterial Diversity and Growth among Preschool Children in Burkina Faso.}, journal = {Am J Trop Med Hyg}, volume = {103}, year = {2020}, month = {2020 12}, pages = {2568-2573}, abstract = {

There is a lack of empirical, prospective human data on the gut microbiome and its relationship with growth, especially in low- and middle-income countries. We prospectively assessed the association between gut microbial diversity and short-term growth in a cohort of preschool children in Burkina Faso to better characterize whether there is any evidence that changes in gut microbial diversity may affect growth. Data were obtained from a randomized controlled trial evaluating the effect of antibiotic administration on gut microbial diversity in preschool children. We followed up the enrolled children for 35 days, with anthropometric measurements at baseline and day 35 and microbial diversity measured at baseline and day 9 (analytic sample, = 155). We estimated linear mixed-effects regression models with household random intercepts to assess the association of Simpson{\textquoteright}s and Shannon{\textquoteright}s alpha diversity with measures of change in anthropometry (e.g., ponderal growth since baseline) and absolute anthropometric measurements (e.g., day 35 weight). We did not find evidence that alpha gut microbial diversity was associated with growth or absolute anthropometric measurements after adjusting for confounding variables. Effect estimates were close to the null ( >= 0.15 for all fully adjusted comparisons), with the association between Simpson{\textquoteright}s alpha diversity and day 35 height (cm) farthest from the null (coefficient = -0.03, 95\% CI: -0.07, 0.01). The change in gut microbial diversity also was not associated with the change in anthropometry in crude or adjusted models. Future research is needed to explore whether gut diversity has an impact on growth over a longer time period, in both healthy and malnourished children.

}, keywords = {Anti-Bacterial Agents, Bacteria, Burkina Faso, Child Development, Child, Preschool, Female, Gastrointestinal Microbiome, Humans, Infant, Male, Nutritional Status, Prospective Studies}, issn = {1476-1645}, doi = {10.4269/ajtmh.20-0059}, author = {Digitale, Jean and Sie, Ali and Coulibaly, Boubacar and Ouermi, Lucienne and Dah, Clarisse and Tapsoba, Charlemagne and B{\"a}rnighausen, Till and Lebas, Elodie and Arzika, Ahmed M and Glymour, Medellena Maria and Keenan, Jeremy D and Doan, Thuy and Oldenburg, Catherine E} } @article {171, title = {Gut Resistome After Oral Antibiotics in Preschool Children in Burkina Faso: A Randomized, Controlled Trial.}, journal = {Clin Infect Dis}, volume = {70}, year = {2020}, month = {2020 01 16}, pages = {525-527}, abstract = {

We evaluated the effect of systemic antibiotics (azithromycin, amoxicillin, cotrimoxazole, or placebo) on the gut resistome in children aged 6 to 59 months. Azithromycin and cotrimoxazole led to an increase in macrolide and sulfonamide resistance determinants. Resistome expansion can be induced with a single course of antibiotics.

}, keywords = {Anti-Bacterial Agents, Azithromycin, Burkina Faso, Child, Preschool, Gastrointestinal Microbiome, Humans, Infant, Macrolides}, issn = {1537-6591}, doi = {10.1093/cid/ciz455}, author = {Oldenburg, Catherine E and Hinterwirth, Armin and Sie, Ali and Coulibaly, Boubacar and Ouermi, Lucienne and Dah, Clarisse and Tapsoba, Charlemagne and Cummings, Susie L and Zhong, Lina and Chen, Cindi and Sarkar, Samarpita and B{\"a}rnighausen, Till and Lietman, Thomas M and Keenan, Jeremy D and Doan, Thuy} } @article {206, title = {Rapid Reduction of Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial.}, journal = {Am J Trop Med Hyg}, volume = {103}, year = {2020}, month = {2020 09}, pages = {1266-1269}, abstract = {

has emerged as a potential important cause of childhood morbidity in sub-Saharan Africa. Biannual mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. We conducted a randomized controlled trial in Burkina Faso in which children were randomized in a 1:1 fashion to a 5-day course of azithromycin or placebo to investigate the effect of oral antibiotics on the gut microbiome. We evaluated the changes in the gut microbiome of preschool children treated with azithromycin using metagenomic DNA sequencing. We found that three species were reduced with azithromycin treatment compared with placebo. These results were consistent with other studies that have shown decreases in species after azithromycin treatment, generating the hypothesis that a decrease in may contribute to observations of reduction in mortality following azithromycin distribution.

}, keywords = {Anti-Bacterial Agents, Azithromycin, Burkina Faso, Campylobacter, Campylobacter Infections, Child Mortality, Child, Preschool, Gastrointestinal Microbiome, Humans, Infant, Metagenomics, Sequence Analysis, DNA}, issn = {1476-1645}, doi = {10.4269/ajtmh.19-0940}, author = {Hinterwirth, Armin and Sie, Ali and Coulibaly, Boubacar and Ouermi, Lucienne and Dah, Clarisse and Tapsoba, Charlemagne and Zhong, Lina and Chen, Cindi and Lietman, Thomas M and Keenan, Jeremy D and Doan, Thuy and Oldenburg, Catherine E} }