Evidence map›Paper›PMID 33879263›Full record

ArticlePilot and feasibility studies2021

Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial.

Kieran S O'Brien, Ali Sié, Clarisse Dah, Millogo Ourohire, Ahmed M Arzika, Valentin Boudo, Elodie Lebas, William W Godwin, Benjamin F Arnold, Catherine E Oldenburg

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03568643 (Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 31% of its field
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.

NCT03568643 phase3completednot on this map

Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2020Enrolled301ConditionsUncomplicated Severe Acute MalnutritionArmsAzithromycin, Amoxicillin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

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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

10 authors at 4 institutions in 4 countries.

Kieran S O'BrienFrancis I Proctor Foundation, University of California, San Francisco, 490 Illinois St, San Francisco, CA, USA.
Ali SiéCentre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Clarisse DahCentre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Millogo OurohireCentre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Ahmed M ArzikaCentre de Recherche et Interventions en Santé Publique, Niamey, Niger.
Valentin BoudoCentre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Elodie LebasFrancis I Proctor Foundation, University of California, San Francisco, 490 Illinois St, San Francisco, CA, USA.
William W GodwinFrancis I Proctor Foundation, University of California, San Francisco, 490 Illinois St, San Francisco, CA, USA.
Benjamin F ArnoldFrancis I Proctor Foundation, University of California, San Francisco, 490 Illinois St, San Francisco, CA, USA.
Catherine E OldenburgFrancis I Proctor Foundation, University of California, San Francisco, 490 Illinois St, San Francisco, CA, USA. catherine.oldenburg@ucsf.edu.ORCID http://orcid.org/0000-0002-0763-399X
Centre de Recherche en Santé de Nouna · BFUniversity of California, San Francisco · USCarl von Ossietzky Universität Oldenburg · DECentre de Recherche Médicale et Sanitaire · NE

Funding

Azithromycin in the Outpatient Management of Severe Acute MalnutritionR21HD100932 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI OLDENBURG, CATHERINE ELIZABETH · 2020 to 2021
$395k
National Institute of Child Health and Human Development 1R21HD100932NICHD NIH HHS R21 HD100932University of California San Francisco NA
6 · The paper itself

Abstract

backgroundGiven the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the efficacy of amoxicillin to improve nutritional recovery or reduce mortality has been mixed. With a long half-life and evidence of efficacy to reduce mortality in high-risk populations, azithromycin is a potential alternative to amoxicillin in the management of SAM. In this pilot study, we aim to compare the efficacy of azithromycin to amoxicillin to improve nutritional outcomes in children with uncomplicated SAM.

methodsThis pilot randomized controlled trial will enroll 300 children with uncomplicated SAM from 6 Centre de Santé et de Promotion Sociale in the Boromo health district in Burkina Faso. Eligible children are randomized to receive a single directly observed dose of oral azithromycin or a 7-day course of oral amoxicillin in addition to the standard package of care for uncomplicated SAM. Enrolled children are followed weekly until nutritional recovery, and all children return for a final study visit at 8 weeks after enrollment. Anthropometric indicators, vital status, and clinical outcomes are monitored at each visit and compared by arm. Primary feasibility outcomes include enrollment potential, refusals, loss to follow-up, and completeness of data collection. The primary clinical outcome is weight gain (g/kg/day) over the 8-week study period. DISCUSSION: This pilot trial will establish the feasibility of conducting a full-scale randomized controlled trial to evaluate alternative antibiotics in this setting and provide preliminary evidence for the efficacy of azithromycin compared to amoxicillin to improve outcomes for children with SAM.

trial registrationThis trial was first registered on clinicaltrials.gov on 26 June 2018 ( NCT03568643 ).

Indexed as

AmoxicillinAzithromycinSevere acute malnutritionWeight gain

Identifiers

PMID33879263
PMCPMC8056624
OpenAlexW3154403021

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.