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

Murdoch Childrens Research Institute2,110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,110

Conditions

Bacterial Infections

Interventions

Azithromycin 500 mg Oral Tablet x 4DRUG

A single prophylactic dose of antibiotic given during labour

Matching PlaceboDRUG

Matching Placebo

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Pregnant women at least 18 years old intending to deliver at Colonial War Memorial Hospital (CWMH) 2. Women who have been admitted to CWMH for delivery at the time of eligibility assessment 3. Women who expect to be available, with their infant, for the duration of the study, and who agree to adhere to all protocol requirements 4. Women who will have a main place of residence within the Greater Suva area for the follow-up period and within a practical distance of the study site to allow compliance with protocol-required visits and follow-up, including attending follow-up at specified clinics 5. Women who have provided written informed consent prior to study-related procedures being performed Exclusion criteria: 1. Women who have a known macrolide allergy 2. Women who have taken antibiotics in the week prior to randomisation 3. A women who is unable or unwilling to provide informed consent for her participation in the trial or the participation of her infant 4. Women who decide prior to randomisation that they are no longer willing to participate or to have their infant participate 5. Women who have ever received, or who are anticipated to receive during the study period, any investigational agent other than the study drug 6. Women who are CWMH, Murdoch Children's Research Institute (MCRI) or study site employees who work directly with study staff, or who are working on the study 7. Women taking warfarin due to the potential for drug interactions with azithromycin 8. Women with any cardiac abnormality 9. Women taking other medications known to prolong the QT interval such as antiarrhythmics; antipsychotic agents; antidepressants; and fluoroquinolones; 10. Women with known electrolyte disturbances: including in cases of hypokalaemia and hypomagnesaemia 11. Women who will undergo general anaesthetic for delivery 12. Women carrying a foetus with intrauterine death confirmed before randomisation 13. Women carrying a foetus with a prognosis unlikely to survive 14. Women with known HIV infection and/or taking nelfinavir 15. Women who have participated in the study during a previous pregnancy 16. Women who have been admitted for management of premature labour who have unruptured membranes (This is a temporary exclusion such that the participant may be assessed for eligibility again in the same or a subsequent admission to CWMH). 17. Women with renal impairment 18. Women with hepatic impairment 19. Women with myasthenia gravis 20. Women who are taking any ergot medications

Locations (1)

Colonial War Memorial Hospital and Mother and Child Health Clinics

Suva, Central, Fiji

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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;

Time frame: Birth to 12 Months

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

Time frame: 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;

Time frame: 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

Time frame: Delivery to 12 months

Data from ClinicalTrials.gov

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