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Bacterial InfectionsPhase 3PreYIALNCT03925480

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

A Phase 3 study testing Azithromycin 500 mg Oral Tablet x 4 in people with Bacterial Infections, run by Murdoch Childrens Research Institute at 1 site in Fiji.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Bacterial Infections
What is being tested?
Azithromycin 500 mg Oral Tablet x 4
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,110 participants
Where
1 siteFiji
Study dates
1 Jul 2019to 28 Feb 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant women at least 18 years old intending to deliver at Colonial War Memorial Hospital (CWMH)
  • Women who have been admitted to CWMH for delivery at the time of eligibility assessment
  • Women who expect to be available, with their infant, for the duration of the study, and who agree to adhere to all protocol requirements
  • 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
  • Women who have provided written informed consent prior to study-related procedures being performed

Who cannot join

  • Women who have a known macrolide allergy
  • Women who have taken antibiotics in the week prior to randomisation
  • A women who is unable or unwilling to provide informed consent for her participation in the trial or the participation of her infant
  • Women who decide prior to randomisation that they are no longer willing to participate or to have their infant participate
  • Women who have ever received, or who are anticipated to receive during the study period, any investigational agent other than the study drug
  • 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
Show all 20Show fewer
  • Women taking warfarin due to the potential for drug interactions with azithromycin
  • Women with any cardiac abnormality
  • Women taking other medications known to prolong the QT interval such as antiarrhythmics; antipsychotic agents; antidepressants; and fluoroquinolones;
  • Women with known electrolyte disturbances: including in cases of hypokalaemia and hypomagnesaemia
  • Women who will undergo general anaesthetic for delivery
  • Women carrying a foetus with intrauterine death confirmed before randomisation
  • Women carrying a foetus with a prognosis unlikely to survive
  • Women with known HIV infection and/or taking nelfinavir
  • Women who have participated in the study during a previous pregnancy
  • 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).
  • Women with renal impairment
  • Women with hepatic impairment
  • Women with myasthenia gravis
  • Women who are taking any ergot medications

Trial locations and contacts

1 site in 1 country.

Fiji1 site

  • Colonial War Memorial Hospital and Mother and Child Health Clinics

    Suva, Central

About this study

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

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.

Being tested
Azithromycin 500 mg Oral Tablet x 4, Matching Placebo
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azithromycin 500 mg Oral Tablet x 4Drug

    A single prophylactic dose of antibiotic given during labour

  • Matching PlaceboDrug

    Matching Placebo

Study groups in NCT03925480
Study groupRoleWhat they receive
AzithromycinExperimentalA single 2g dose of Azithromycin
Receives: Drug: Azithromycin 500 mg Oral Tablet x 4
PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (13)

  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;

    Measured: 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

    Measured: 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;

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: Delivery/birth to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completion25 May 2022
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Blinded, randomized, placebo-controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03925480
Sponsor's protocol ID
HREC 38057
Acronym
PreYIAL
Status last verified
Aug 2025
First submitted
4 Apr 2019
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azithromycin 500 mg Oral Tablet x 4 in people with Bacterial Infections, run by Murdoch Childrens Research Institute at 1 site in Fiji.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Fiji. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of skin and soft tissue infection by 3 months of age in infants (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03925480, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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