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CompletedNCT03925480PreYIALUpdated Sep 8, 2025

Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL) Trial

A Phase 3 interventional study of Azithromycin 500 mg Oral Tablet x 4 and Matching Placebo in Bacterial Infections, sponsored by Murdoch Childrens Research Institute. Completed at 1 site in Fiji. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Murdoch Childrens Research Institute · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,110
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

A trial to assess cumulative incidence of skin and soft tissue infections (SSTI) in infants (by three months of age) born to mothers receiving a single-dose of 2 grams of oral azithromycin during labour (or immediately prior to delivery in the case of caesarean section), compared to infants whose mothers received placebo.

Read the detailed description

PreYIAL is a Phase III, double-blind, randomised, placebo controlled two arm trial of a single 2g dose of azithromycin or placebo, administered to women who have been admitted for delivery of their baby (either following onset of labour or for caesarean section).

The trial includes an estimated 2110 mothers/infant pairs (1055 per arm), with 12 months of follow-up for the mother/infant pair.

A swab-study within the main study involves 940 of the mother/infant pairs enrolled and involves follow-up for bacterial carriage outcomes, for 12 months.These swab-study participants will also be included in assessments of the infant and maternal microbiome.

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Conditions studied

  • Bacterial Infections

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03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 2,110 is above the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Murdoch Childrens Research Institute is the lead sponsor of 96 studies on the registry; 34 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Pregnant women at least 18 years old intending to deliver at Colonial War Memorial Hospital (CWMH)
  2. Women who have been admitted to CWMH for delivery at the time of eligibility assessment
  3. Women who expect to be available, with their infant, for the duration of the study, and who agree to adhere to all protocol requirements
  4. Women who will have a main place of residence within the Greater Suva area for the follow-up period and within a practical distance of the study site to allow compliance with protocol-required visits and follow-up, including attending follow-up at specified clinics
  5. Women who have provided written informed consent prior to study-related procedures being performed

Exclusion criteria

Exclusion criteria:

  1. Women who have a known macrolide allergy
  2. Women who have taken antibiotics in the week prior to randomisation
  3. A women who is unable or unwilling to provide informed consent for her participation in the trial or the participation of her infant
  4. Women who decide prior to randomisation that they are no longer willing to participate or to have their infant participate
  5. Women who have ever received, or who are anticipated to receive during the study period, any investigational agent other than the study drug
  6. Women who are CWMH, Murdoch Children's Research Institute (MCRI) or study site employees who work directly with study staff, or who are working on the study
  7. Women taking warfarin due to the potential for drug interactions with azithromycin
  8. Women with any cardiac abnormality
  9. Women taking other medications known to prolong the QT interval such as antiarrhythmics; antipsychotic agents; antidepressants; and fluoroquinolones;
  10. Women with known electrolyte disturbances: including in cases of hypokalaemia and hypomagnesaemia
  11. Women who will undergo general anaesthetic for delivery
  12. Women carrying a foetus with intrauterine death confirmed before randomisation
  13. Women carrying a foetus with a prognosis unlikely to survive
  14. Women with known HIV infection and/or taking nelfinavir
  15. Women who have participated in the study during a previous pregnancy
  16. Women who have been admitted for management of premature labour who have unruptured membranes (This is a temporary exclusion such that the participant may be assessed for eligibility again in the same or a subsequent admission to CWMH).
  17. Women with renal impairment
  18. Women with hepatic impairment
  19. Women with myasthenia gravis
  20. Women who are taking any ergot medications
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,110 participants (actual)

Study arms

  • Experimental
    Azithromycin

    A single 2g dose of Azithromycin

    Drug: Azithromycin 500 mg Oral Tablet x 4

  • Placebo comparator
    Placebo

    Matching Placebo

    Drug: Matching Placebo

Interventions

  • DrugAzithromycin 500 mg Oral Tablet x 4

    A single prophylactic dose of antibiotic given during labour

  • DrugMatching Placebo

    Matching Placebo

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What researchers measure

Primary outcomes

  1. Cumulative incidence of skin and soft tissue infection by 3 months of age in infants

    Born to mothers receiving a single dose of 2g Azithromycin during labour. Assessed by history and physical examination at 7 days, 6 weeks and 3 months.

    Time frame: 3 months

Secondary outcomes

  1. Cumulative incidence of skin and soft tissue infection, and other infections by 12 months of age in infants

    To compare intervention and placebo groups with regard to the cumulative incidence of infant infection (meningitis, sepsis, pneumonia, SSTI, fever, diarrhoea, urinary tract infection) up to 12 months of age;

    Time frame: Birth to 12 Months

  2. Cumulative incidence of maternal infection by 6 weeks and 12 months post-delivery

    To compare intervention and placebo groups with regard to the cumulative incidence of maternal infection (mastitis, sepsis, post-operative wound infections, SSTI, fever, meningitis, pneumonia, abdominal or pelvic abscess, endometritis, urinary tract infection, pyelonephritis) by six weeks post-delivery, and similarly up to 12 months post-delivery

    Time frame: Delivery to 12 months

  3. Cumulative incidence of antibiotic usage by 12 months in infants

    To compare intervention and placebo groups with regard to the cumulative incidence of the number of courses of antibiotics prescribed to the infant up to 12 months of age;

    Time frame: Birth to 12 months

  4. Cumulative incidence of maternal antibiotic usage by 12 months post-delivery

    To compare intervention and placebo groups with regard to the cumulative incidence of the number of courses of antibiotics prescribed to the mother up to 12 months post-delivery

    Time frame: Delivery to 12 months

  5. Number of infant participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1

    To compare the number of adverse events including solicited non serious adverse events and all serious adverse events as per study specific definitions throughout the duration of the study.

    Time frame: Birth to 12 months

  6. Number of maternal participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1

    To compare the number of adverse events including solicited non serious adverse events and all serious adverse events as per study specific definitions throughout the duration of the study.

    Time frame: Delivery to 12 months

  7. Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus as assessed by real-time quantitative PCR (qPCR) from impetigo swabs

    The proportion of participants that have Staphylococcus aureus and/or Group A streptoccoccus detected by qPCR from impetigo swabs at key time points throughout the duration of the study, between the two groups

    Time frame: Delivery/birth to 12 months

  8. Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus with azithromycin nonsusceptibility cultured from impetigo swabs.

    The proportion of participants that have Staphylococcus aureus and/or Group A streptococcus that is non susceptible to azithromycin cultured from impetigo swabs at key time points throughout the duration of the study, between the two groups

    Time frame: Delivery/birth to 12 months

  9. Swab study outcome - Prevalence of bacterial carriage as assessed by real-time quantitative PCR (qPCR)

    Bacterial carriage, the proportion of participants that have at least one of the following bacterial species including GBS, SA, SPN, GAS or E. coli, assessed by qPCR at key time points throughout the duration of the study, between the two groups

    Time frame: Delivery/birth to 12 months

  10. Swab study outcome - Density of bacterial carriage as assessed by real-time quantitative PCR (qPCR)

    Density of bacterial carriage, reported as log 10 genome equivalents/ml, of the participants that have at least one of the following bacterial species including GBS, SA, SPN, GAS or E. coli, assessed by qPCR at key time points throughout the duration of the study, between the two groups

    Time frame: Delivery/birth to 12 months

  11. Swab study outcome - Risk of maternal carriage identified through qPCR of common organisms relevant to Sexually Transmitted Infections (STI)

    Maternal carriage of common organisms relevant to Sexually Transmitted Infections (STI) (including Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, HSV-1 and HSV-2) as detected by qPCR at key time points throughout the duration of the study, between the two groups.

    Time frame: Delivery/birth to 6 months

  12. Swab study outcome - Risk of antibiotic nonsusceptibility in culture isolates

    Antibiotic non susceptibility, based on the proportion of samples from mothers and infants that are non susceptible to antibiotics cultured in the two arms, at key time points throughout the duration of the study

    Time frame: Delivery/birth to 12 months

  13. Swab study outcome - The prevalence of infants with diagnoses that have been associated with microbiome dysbiosis

    To compare the infant and maternal microbiome of specified body sites at key time points in the intervention and placebo groups

    Time frame: Delivery/birth to 6 months

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Study locations

1 site
  • Colonial War Memorial Hospital and Mother and Child Health Clinics
    Suva, Central, Fiji
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References and documents

Publications

  • Hume-Nixon M, Ratu T, Clark S, Nguyen CD, Neal EFG, Pell CL, Bright K, Watts E, Hart J, Mulholland K, Fong J, Rafai E, Sakumeni K, Tuibeqa I, Satzke C, Steer A, Russell FM. Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial. BMJ Open. 2022 Dec 1;12(12):e061157. doi: 10.1136/bmjopen-2022-061157. PubMed 36456016 ↗
  • Hume-Nixon M, Clark S, Ratu T, Nguyen CD, Neal EFG, Bright K, Strobel AG, Watts E, Hart J, Fong J, Rafai E, Sakumeni K, Steer A, Tuibeqa I, Russell FM. 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. BMC Med. 2025 Apr 28;23(1):246. doi: 10.1186/s12916-025-04070-6. PubMed 40289086 ↗
  • Hume-Nixon M, Clark S, Ratu T, Nguyen C, Neal EFG, Bright K, Strobel AG, Watts E, Hart J, Fong JJ, Rafai E, Sakumeni K, Steer A, Vereti I, Russell F. 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. BMJ Glob Health. 2026 Mar 4;11(3):e019851. doi: 10.1136/bmjgh-2025-019851. PubMed 41781021 ↗

Individual participant data

Plan to share: Yes — The de-identified data set collected for this analysis of the PreYIAL trial will be available six months after publication of the primary outcome. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03925480
Lead sponsor
Murdoch Childrens Research Institute
Collaborators
Ministry of Health, Fiji
Responsible party
Sponsor
First posted
Apr 24, 2019
Start date
Jul 1, 2019
Primary completion
May 25, 2022
Completion
Feb 28, 2023
Last update
Sep 8, 2025

Study contacts

Fiona M Russell, BMBS PhD
principal investigator · Murdoch Childrens Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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