Evidence map›Paper›PMID 40289086›Full record

Trial reportBMC medicine2025

The safety and efficacy of a single dose of oral azithromycin given in labour to prevent skin and soft tissue infections in young infants in Fiji: a randomised controlled trial.

Maeve Hume-Nixon, Stephanie Clark, Tupou Ratu, Cattram D Nguyen, Eleanor F G Neal, Kathryn Bright, Aneley Getahun Strobel, Emma Watts, John Hart, James Fong and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03925480 (Preventing Young Infant Infections Using Azithromycin in Labour), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03925480 phase3completednot on this map

Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL): a Blinded, Randomised, Placebo-controlled Trial

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2019 to 2023Enrolled2,110ConditionsBacterial InfectionsArmsAzithromycin 500 mg Oral Tablet x 4, Matching Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
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

15 authors.

Maeve Hume-NixonDepartment of Paediatrics, The University of Melbourne, Melbourne, Australia. Maeve.humenixon@gmail.com.
Stephanie ClarkAsia-Pacific Health, Murdoch Children's Research Institute, Melbourne, Australia.
Tupou RatuAsia-Pacific Health, Murdoch Children's Research Institute, Melbourne, Australia.
Cattram D NguyenDepartment of Paediatrics, The University of Melbourne, Melbourne, Australia.
Eleanor F G NealDepartment of Paediatrics, The University of Melbourne, Melbourne, Australia.
Kathryn BrightAsia-Pacific Health, Murdoch Children's Research Institute, Melbourne, Australia.
Aneley Getahun StrobelDepartment of Microbiology and Immunology, The University of Melbourne at Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Emma WattsNew Vaccines, Murdoch Children's Research Institute, Melbourne, Australia.
John HartDepartment of Paediatrics, The University of Melbourne, Melbourne, Australia.
James FongMinistry of Health & Medical Services, Suva, Fiji.
Eric RafaiMinistry of Health & Medical Services, Suva, Fiji.
Kelera SakumeniMinistry of Health & Medical Services, Suva, Fiji.
Andrew SteerDepartment of Paediatrics, The University of Melbourne, Melbourne, Australia.
Ilisapeci TuibeqaMinistry of Health & Medical Services, Suva, Fiji.
Fiona M RussellDepartment of Paediatrics, The University of Melbourne, Melbourne, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProphylactic azithromycin in pregnancy has been shown to lower infections in birthing parents and newborns, particularly skin and soft tissue infections (SSTIs) which are common in Fiji. We aimed to determine the safety and efficacy of 2 g of oral azithromycin administered during labour on infant SSTIs.

methodsThis blinded, randomised placebo-control trial included healthy, pregnant adults and their infants presenting for delivery at a tertiary hospital in Suva, Fiji. Participants in labour were randomly assigned a single dose of 2 g of oral azithromycin or placebo in a 1:1 ratio, stratified by ethnicity. Active and placebo drugs were identical to mask treatment allocation. The primary outcome was cumulative incidence of infant SSTIs by 3 months of age. Intention-to-treat analysis was used and included participants with SSTI data collected at all visits. Safety outcomes were described as percentages by arm at specified time points.

resultsFrom June 2019 to January 2022, 2110 pregnant persons were enrolled and randomised, with 1059 and 1063 births in the azithromycin and placebo groups, respectively. 1671 infants were included in the primary analysis (816 in azithromycin and 855 in placebo group). We found a 27% decrease in infant SSTIs in the azithromycin group (5.8%; 95% CI 4.4-7.6) compared to placebo (7.8%; 95% CI 6.2-9.8), but the 95% confidence interval crossed the null value (RR 0.73; 95% CI 0.51-1.06). We observed similar numbers of serious adverse events in both arms, and no cases of infant hypertrophic pyloric stenosis.

conclusionsThere was a modest relative reduction in infant SSTIs but this was small in absolute terms with no statistically discernible difference. Our findings do not support routine intrapartum azithromycin prophylaxis for this outcome alone. However, the rates of SSTIs highlight the importance of prevention and timely treatment in Fiji.

trial registration2019-04-18, ClinicalTrials.gov identifier: NCT03925480.

Indexed as

Anti-Bacterial AgentsAntibiotic ProphylaxisAzithromycinSoft Tissue InfectionsAdministration, OralAdultFemaleFijiHumansInfantInfant, NewbornLabor, ObstetricMalePregnancyYoung AdultAnti-Bacterial AgentsAzithromycinAzithromycinGlobal Child HealthGlobal healthIntrapartum azithromycinPaediatric infectious diseaseSkin infections

Identifiers

PMID40289086
PMCPMC12036277

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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.