NCT03925480

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,110 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Azithromycin 500 mg Oral Tablet x 4	A single prophylactic dose of antibiotic given during labour
DRUG	Matching Placebo	Matching Placebo

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-05-25
• Completion: 2023-02-28
• First posted: 2019-04-24
• Last updated: 2025-09-08

Locations

1 site across 1 country: Fiji