Evidence map›Paper›PMID 40592757›Full record

ArticleBMJ open2025

Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial.

Mamadou Bountogo, Alphonse Zakane, Thierry A Ouedraogo, Lucienne Ouermi, Guillaume Compaoré, Adama Compaoré, Boubacar Coulibaly, Fla Koueta, Hadley R Burroughs, Ian Fetterman and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06010719 (Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06010719 phase4recruitingnot on this map

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition: the AMOUR Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2024 to 2028Enrolled3,000ConditionsMalnutrition, Child, Severe Acute MalnutritionArmsAzithromycin, Amoxicillin, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Mamadou BountogoCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Alphonse ZakaneCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Thierry A OuedraogoCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Lucienne OuermiCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Guillaume CompaoréCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Adama CompaoréCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Boubacar CoulibalyCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Fla KouetaCentre Hospitalier Universitaire Pédiatrique Charles De Gaulle, Ouagadougou, Burkina Faso.
Hadley R BurroughsUniversity of California San Francisco, San Francisco, California, USA.
Ian FettermanUniversity of California San Francisco, San Francisco, California, USA.
Jessica L La MonsUniversity of California San Francisco, San Francisco, California, USA.
Elodie LebasFrancis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.
Thuy DoanFrancis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.
Michelle HsiangMalaria Elimination Initiative, University of California San Francisco (UCSF), San Francisco, California, USA.
Kieran Sunanda O'BrienFrancis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.
Benjamin ArnoldFrancis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.ORCID http://orcid.org/0000-0001-6105-7295
Ali SieCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Catherine E OldenburgUniversity of California San Francisco, San Francisco, California, USA catherine.oldenburg@ucsf.edu.ORCID http://orcid.org/0000-0002-0763-399X

Funding

Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition: the AMOUR trialR01HD111532 · NICHD · WASHINGTON UNIVERSITY · PI Catherine Elizabeth Oldenburg · 2024 to 2026
$1.9M
NICHD NIH HHS R01 HD111532
6 · The paper itself

Abstract

introductionAmoxicillin 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 Comité d'Ethique pour la Recherche en Santé 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.

Indexed as

AmoxicillinAnti-Bacterial AgentsAzithromycinSevere Acute MalnutritionChild, PreschoolDouble-Blind MethodFemaleHumansInfantMaleRandomized Controlled Trials as TopicAmoxicillinAnti-Bacterial AgentsAzithromycinAfrica South of the SaharaNutritionRandomized Controlled TrialWeight Gain

Identifiers

PMID40592757
PMCPMC12215140

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.