Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL) Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bacterial Infections
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Blinded, randomized, placebo-controlled trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Matched drug and placeboPrimary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT03925480
- Collaborators
- Ministry of Health, Fiji
- Investigators
- Principal Investigator: Fiona M Russell, BMBS PhD Murdoch Childrens Research Institute
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