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

NCT03925480 | Completed Phase 3 DMC

• 1 other identifier: HREC 38057
• Study Type: interventional
• Target: 2,110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Infections

Outcome Measures

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.

  3 months

Secondary Outcomes (13)

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

  Birth to 12 Months

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

  Delivery to 12 months

• Cumulative incidence of antibiotic usage by 12 months in infants

  Birth to 12 months

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

  Delivery to 12 months

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

  Birth to 12 months

Study Arms (2)

Azithromycin

EXPERIMENTAL

A single 2g dose of Azithromycin

Drug: Azithromycin 500 mg Oral Tablet x 4

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Matching Placebo

Interventions

Azithromycin 500 mg Oral Tablet x 4 DRUG

A single prophylactic dose of antibiotic given during labour

Azithromycin

Matching Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Ministry of Health, Fiji: collaborator

Study Sites (1)

Colonial War Memorial Hospital and Mother and Child Health Clinics

Suva, Central, Fiji

Location

Related Publications (2)

• 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.

  PMID: 36456016 BACKGROUND

• 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.

  PMID: 40289086 RESULT

MeSH Terms

Conditions

Bacterial Infections

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Fiona M Russell, BMBS PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Matched drug and placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 24, 2019
• Study Start: July 1, 2019
• Primary Completion: May 25, 2022
• Study Completion: February 28, 2023
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 6 months following publication of primary results for 15 years
• Access Criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the DSMB must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.

Locations

FI (1)