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

NCT03925480 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2110

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

DRUG

Azithromycin 500 mg Oral Tablet x 4

A single prophylactic dose of antibiotic given during labour

DRUG

Matching Placebo

Matching Placebo

Sponsors & Collaborators

  • Ministry of Health, Fiji

    collaborator OTHER_GOV

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Fiona M Russell, BMBS PhD · Murdoch Childrens Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-05-25
Completion
2023-02-28

Countries

  • Fiji

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925480 on ClinicalTrials.gov