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| Name | Class |
|---|---|
| Ministry of Health, Fiji | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | A single 2g dose of Azithromycin |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin 500 mg Oral Tablet x 4 | Drug | A single prophylactic dose of antibiotic given during labour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of skin and soft tissue infection by 3 months of age in infants | Born to mothers receiving a single dose of 2g Azithromycin during labour. Assessed by history and physical examination at 7 days, 6 weeks and 3 months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of skin and soft tissue infection, and other infections by 12 months of age in infants | To compare intervention and placebo groups with regard to the cumulative incidence of infant infection (meningitis, sepsis, pneumonia, SSTI, fever, diarrhoea, urinary tract infection) up to 12 months of age; | Birth to 12 Months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fiona M Russell, BMBS PhD | Murdoch Childrens Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colonial War Memorial Hospital and Mother and Child Health Clinics | Suva | Central | Fiji |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36456016 | 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. | |
| 40289086 |
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The de-identified data set collected for this analysis of the PreYIAL trial will be available six months after publication of the primary outcome.
The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing
From 6 months following publication of primary results for 15 years
Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the DSMB must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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Blinded, randomized, placebo-controlled trial
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Matched drug and placebo
| Matching Placebo | Drug | Matching Placebo |
|
| Cumulative incidence of maternal infection by 6 weeks and 12 months post-delivery |
To compare intervention and placebo groups with regard to the cumulative incidence of maternal infection (mastitis, sepsis, post-operative wound infections, SSTI, fever, meningitis, pneumonia, abdominal or pelvic abscess, endometritis, urinary tract infection, pyelonephritis) by six weeks post-delivery, and similarly up to 12 months post-delivery |
| Delivery to 12 months |
| Cumulative incidence of antibiotic usage by 12 months in infants | To compare intervention and placebo groups with regard to the cumulative incidence of the number of courses of antibiotics prescribed to the infant up to 12 months of age; | Birth to 12 months |
| Cumulative incidence of maternal antibiotic usage by 12 months post-delivery | To compare intervention and placebo groups with regard to the cumulative incidence of the number of courses of antibiotics prescribed to the mother up to 12 months post-delivery | Delivery to 12 months |
| Number of infant participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1 | To compare the number of adverse events including solicited non serious adverse events and all serious adverse events as per study specific definitions throughout the duration of the study. | Birth to 12 months |
| Number of maternal participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1 | To compare the number of adverse events including solicited non serious adverse events and all serious adverse events as per study specific definitions throughout the duration of the study. | Delivery to 12 months |
| Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus as assessed by real-time quantitative PCR (qPCR) from impetigo swabs | The proportion of participants that have Staphylococcus aureus and/or Group A streptoccoccus detected by qPCR from impetigo swabs at key time points throughout the duration of the study, between the two groups | Delivery/birth to 12 months |
| Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus with azithromycin nonsusceptibility cultured from impetigo swabs. | The proportion of participants that have Staphylococcus aureus and/or Group A streptococcus that is non susceptible to azithromycin cultured from impetigo swabs at key time points throughout the duration of the study, between the two groups | Delivery/birth to 12 months |
| Swab study outcome - Prevalence of bacterial carriage as assessed by real-time quantitative PCR (qPCR) | Bacterial carriage, the proportion of participants that have at least one of the following bacterial species including GBS, SA, SPN, GAS or E. coli, assessed by qPCR at key time points throughout the duration of the study, between the two groups | Delivery/birth to 12 months |
| Swab study outcome - Density of bacterial carriage as assessed by real-time quantitative PCR (qPCR) | Density of bacterial carriage, reported as log 10 genome equivalents/ml, of the participants that have at least one of the following bacterial species including GBS, SA, SPN, GAS or E. coli, assessed by qPCR at key time points throughout the duration of the study, between the two groups | Delivery/birth to 12 months |
| Swab study outcome - Risk of maternal carriage identified through qPCR of common organisms relevant to Sexually Transmitted Infections (STI) | Maternal carriage of common organisms relevant to Sexually Transmitted Infections (STI) (including Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, HSV-1 and HSV-2) as detected by qPCR at key time points throughout the duration of the study, between the two groups. | Delivery/birth to 6 months |
| Swab study outcome - Risk of antibiotic nonsusceptibility in culture isolates | Antibiotic non susceptibility, based on the proportion of samples from mothers and infants that are non susceptible to antibiotics cultured in the two arms, at key time points throughout the duration of the study | Delivery/birth to 12 months |
| Swab study outcome - The prevalence of infants with diagnoses that have been associated with microbiome dysbiosis | To compare the infant and maternal microbiome of specified body sites at key time points in the intervention and placebo groups | Delivery/birth to 6 months |
| Result |
| 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. |
| 41781021 | Derived | 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. |
| Organic Chemicals |