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

Bacterial Infections Clinical Trial

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

Clinical 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 placebo.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03925480
Study type Interventional
Source Murdoch Childrens Research Institute
Contact
Status Completed
Phase Phase 3
Start date July 1, 2019
Completion date February 28, 2023
View Details
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