Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL) Trial
- Conditions
- Bacterial Infections
- Interventions
- Drug: Matching Placebo
- Registration Number
- NCT03925480
- Lead Sponsor
- Murdoch Childrens Research Institute
- Brief 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.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Matching Placebo Matching Placebo Azithromycin Azithromycin 500 mg Oral Tablet x 4 A single 2g dose of Azithromycin
- Primary Outcome Measures
Name Time Method Cumulative incidence of skin and soft tissue infection by 3 months of age in infants 3 months 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.
- Secondary Outcome Measures
Name Time Method Cumulative incidence of skin and soft tissue infection, and other infections by 12 months of age in infants Birth to 12 Months 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;
Cumulative incidence of maternal infection by 6 weeks and 12 months post-delivery Delivery to 12 months 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
Cumulative incidence of antibiotic usage by 12 months in infants Birth to 12 months 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;
Cumulative incidence of maternal antibiotic usage by 12 months post-delivery Delivery to 12 months 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
Number of infant participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1 Birth to 12 months 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.
Number of maternal participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1 Delivery to 12 months 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.
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 Delivery/birth to 12 months 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
Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus with azithromycin nonsusceptibility cultured from impetigo swabs. Delivery/birth to 12 months 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
Swab study outcome - Prevalence of bacterial carriage as assessed by real-time quantitative PCR (qPCR) Delivery/birth to 12 months 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
Swab study outcome - Density of bacterial carriage as assessed by real-time quantitative PCR (qPCR) Delivery/birth to 12 months 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
Swab study outcome - Risk of antibiotic nonsusceptibility in culture isolates Delivery/birth to 12 months 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
Swab study outcome - Risk of maternal carriage identified through qPCR of common organisms relevant to Sexually Transmitted Infections (STI) Delivery/birth to 6 months 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.
Swab study outcome - The prevalence of infants with diagnoses that have been associated with microbiome dysbiosis Delivery/birth to 6 months To compare the infant and maternal microbiome of specified body sites at key time points in the intervention and placebo groups
Trial Locations
- Locations (1)
Colonial War Memorial Hospital and Mother and Child Health Clinics
🇫🇯Suva, Central, Fiji