{
  "abstract": "Introduction Our Bulabula MaPei trial of azithromycin administered during labour in Fiji found no evidence of a reduction in the primary endpoint of infant skin and soft tissue infections (SSTIs) at 3 months of age. Here, we determine the efficacy of this intervention on several secondary outcomes.Methods This randomised controlled trial included healthy pregnant adults presenting to hospital in labour. Prior to delivery, participants were randomly assigned a single dose of 2 g of oral azithromycin or placebo that were identical in appearance to mask treatment allocation, in a 1:1 ratio stratified by ethnicity. Cumulative incidence of infections and antibiotic prescription was compared using an intention-to-treat analysis of complete cases. Adverse events described as proportions by group at specified time points.Results From June 2019 to January 2022, we enrolled 2110 pregnant people and their infants (n=2122; azithromycin n=1059; placebo n=1063). At 3 months, the cumulative incidence of infant infections was 13.6% in the azithromycin group compared with 17.3% in the placebo group (risk ratio (RR) 0.79; 95% CI 0.63 to 0.99; p=0.038). Infections among birthing parents, including SSTIs, were reduced with the greatest effect 1 week postdelivery (infections: RR 0.31; 95% CI 0.13 to 0.71; p=0.006, SSTIs: RR 0.25; 95% CI 0.08 to 0.75; p=0.013) but with a diminishing effect up to 6 months postdelivery. There was no effect on the prescription of antibiotics at any time point.Conclusions Intrapartum azithromycin prevents a variety of infections for birthing parents and infants up to 12 months post partum in Fiji. However, further research is required to identify target populations and better characterise potential impacts on antimicrobial resistance and the infant microbiome and resistome.Trial registration number NCT03925480.",
  "authors": [
    {
      "affiliations": [
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "Asia-Pacific Health, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Maeve Hume-Nixon"
    },
    {
      "affiliations": [
        "Asia-Pacific Health, Murdoch Children’s Research Institute, Parkville, Victoria, Australia",
        "Ministry of Health and Medical Services, Suva, Fiji"
      ],
      "name": "Stephanie Clark"
    },
    {
      "affiliations": [
        "Asia-Pacific Health, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Tupou Ratu"
    },
    {
      "affiliations": [
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "Asia-Pacific Health, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Cattram Nguyen"
    },
    {
      "affiliations": [
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "Asia-Pacific Health, Murdoch Children’s Research Institute, Parkville, Victoria, Australia",
        "New Vaccines, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Eleanor F G Neal"
    },
    {
      "affiliations": [
        "Asia-Pacific Health, Murdoch Children’s Research Institute, Parkville, Victoria, Australia",
        "New Vaccines, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Kathryn Bright"
    },
    {
      "affiliations": [
        "Department of Microbiology and Immunology, The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia"
      ],
      "name": "Aneley Getahun Strobel"
    },
    {
      "affiliations": [
        "New Vaccines, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Emma Watts"
    },
    {
      "affiliations": [
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "Tropical Diseases Research Group, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "John Hart"
    },
    {
      "affiliations": [
        "Ministry of Health and Medical Services, Suva, Fiji"
      ],
      "name": "James J Fong"
    },
    {
      "affiliations": [
        "Ministry of Health and Medical Services, Suva, Fiji"
      ],
      "name": "Eric Rafai"
    },
    {
      "affiliations": [
        "Ministry of Health and Medical Services, Suva, Fiji"
      ],
      "name": "Kelera Sakumeni"
    },
    {
      "affiliations": [
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "Tropical Diseases Research Group, Murdoch Children’s Research Institute, Parkville, Victoria, Australia",
        "Department of General Medicine, Royal Children's Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Andrew Steer"
    },
    {
      "affiliations": [
        "Ministry of Health and Medical Services, Suva, Fiji"
      ],
      "name": "Ilisapeci Vereti"
    },
    {
      "affiliations": [
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "Asia-Pacific Health, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Fiona Russell"
    }
  ],
  "title": "The efficacy of a single dose of oral azithromycin in labour to prevent infections in infants and birthing parents in Fiji: secondary outcomes from a randomised controlled trial",
  "uid": "bb4792c7-eeff-5052-939c-a5fa27c62a69"
}