At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,110 enrolled
Drug / intervention
Azithromycin 500 mg Oral Tablet x 4 +1 moredrug
Likely dose
Azithromycin 500 mg Oral Tablet x 4from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL): a Blinded, Randomised, Placebo-controlled Trial
In Brief
A Phase 3 clinical trial evaluating Azithromycin 500 mg Oral Tablet x 4 and Matching Placebo for Bacterial Infections. Completed, enrolled 2,110 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Infections
CountriesFiji
CollaboratorsMinistry of Health, Fiji
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartJul 2019
Primary CompletionMay 2022
Study CompletionFeb 2023
TodayJul 2026
First PostedApr 24, 2019
Enrollment StartJul 1, 2019
Primary CompletionMay 25, 2022
Study CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.2 years ago
Interventions
Azithromycin 500 mg Oral Tablet x 4drug
A single prophylactic dose of antibiotic given during labour
Matching Placebodrug
Matching Placebo