drugset / Trial / NCT03925480
Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL) Trial
Phase 3
Completed
2110 enrolled
Murdoch Childrens Research Institute
Ministry of Health, Fiji · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2019-07-01
- Primary completion
- 2022-05-25
- Completion
- 2023-02-28
Publications
- Background Hume-Nixon M, Ratu T, Clark S, Nguyen CD, Neal EFG, Pell CL, Bright K, Watts E, Hart J, Mulholland K, Fong J, Rafai E, Sakumeni K, Tuibeqa I, Satzke C, Steer A, Russell FM. Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial. BMJ Open. 2022 Dec 1;12(12):e061157. doi: 10.1136/bmjopen-2022-061157.
- Results Hume-Nixon M, Clark S, Ratu T, Nguyen CD, Neal EFG, Bright K, Strobel AG, Watts E, Hart J, Fong J, Rafai E, Sakumeni K, Steer A, Tuibeqa I, Russell FM. The safety and efficacy of a single dose of oral azithromycin given in labour to prevent skin and soft tissue infections in young infants in Fiji: a randomised controlled trial. BMC Med. 2025 Apr 28;23(1):246. doi: 10.1186/s12916-025-04070-6.
- Hume-Nixon M, Clark S, Ratu T, Nguyen C, Neal EFG, Bright K, Strobel AG, Watts E, Hart J, Fong JJ, Rafai E, Sakumeni K, Steer A, Vereti I, Russell F. The efficacy of a single dose of oral azithromycin in labour to prevent infections in infants and birthing parents in Fiji: secondary outcomes from a randomised controlled trial. BMJ Glob Health. 2026 Mar 4;11(3):e019851. doi: 10.1136/bmjgh-2025-019851.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 2 g | Oral |