@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 {1161, title = {Ocular Rosacea microBiome Study (ORBS)-sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial.}, journal = {Trials}, volume = {23}, year = {2022}, month = {2022 Dec 20}, pages = {1033}, abstract = {

BACKGROUND: Ocular rosacea is common and is often managed with long-term antibiotic treatment. Doxycycline is the most commonly selected antibiotic for the treatment of rosacea. As there is no established standard of care treatment dose for rosacea, prescribed doses of doxycycline vary widely. The FDA classifies 40\ mg daily dose of doxycycline for ocular rosacea as sub-microbial in comparison to an antibiotic dose of 200\ mg daily. However, this "sub-microbial" dose has never been evaluated in patients with ocular rosacea, and even the sub-microbial dose has potential to alter systemic mucosa flora. Here, we present a randomized controlled trial using RNA sequencing to fully characterize the impact of sub-microbial antibiotic dosing of doxycycline on antimicrobial resistance and bacterial composition of the ocular and gut flora.

METHODS: In a triple-masked parallel randomized control trial, patients with ocular rosacea will be randomized to three arms: a 40-mg dose of doxycycline, a 200-mg antibiotic dose of doxycycline, or placebo. Collected rectal and lower eyelid samples will be compared for frequency of antimicrobial resistance genetic determinants and microbiome diversity. A subjective ocular surface disease index survey and objective tear breakup time measurement will be determined.

DISCUSSION: These results will enhance our understanding of the overall systemic impact of long-term systemic sub-microbial antibiotic dosing for the treatment of chronic recurrent ocular inflammatory diseases.

TRIAL REGISTRATION: This trial was registered on ClinicalTrials.org (NCT05296837) on March 22, 2022.

}, keywords = {Anti-Bacterial Agents, Anti-Infective Agents, Doxycycline, Gastrointestinal Microbiome, Humans, Randomized Controlled Trials as Topic, Rosacea}, issn = {1745-6215}, doi = {10.1186/s13063-022-06948-9}, author = {Mahmud, Hamidah and Keenan, Jeremy D and Gonzales, John and Schallhorn, Julie and Chan, Matilda and Arnold, Benjamin and Cavallino, Victoria and Lietman, Thomas M and Doan, Thuy and Seitzman, Gerami D} }