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

Murdoch Childrens Research Institute

Status and phase

Completed

Phase 3

Conditions

Bacterial Infections

Treatments

Drug: Matching Placebo

Drug: Azithromycin 500 mg Oral Tablet x 4

Study type

Interventional

Funder types

Other

Identifiers

NCT03925480

HREC 38057

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,110 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pregnant women at least 18 years old intending to deliver at Colonial War Memorial Hospital (CWMH)
Women who have been admitted to CWMH for delivery at the time of eligibility assessment
Women who expect to be available, with their infant, for the duration of the study, and who agree to adhere to all protocol requirements
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
Women who have provided written informed consent prior to study-related procedures being performed

Exclusion criteria

Women who have a known macrolide allergy
Women who have taken antibiotics in the week prior to randomisation
A women who is unable or unwilling to provide informed consent for her participation in the trial or the participation of her infant
Women who decide prior to randomisation that they are no longer willing to participate or to have their infant participate
Women who have ever received, or who are anticipated to receive during the study period, any investigational agent other than the study drug
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
Women taking warfarin due to the potential for drug interactions with azithromycin
Women with any cardiac abnormality
Women taking other medications known to prolong the QT interval such as antiarrhythmics; antipsychotic agents; antidepressants; and fluoroquinolones;
Women with known electrolyte disturbances: including in cases of hypokalaemia and hypomagnesaemia
Women who will undergo general anaesthetic for delivery
Women carrying a foetus with intrauterine death confirmed before randomisation
Women carrying a foetus with a prognosis unlikely to survive
Women with known HIV infection and/or taking nelfinavir
Women who have participated in the study during a previous pregnancy
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).
Women with renal impairment
Women with hepatic impairment
Women with myasthenia gravis
Women who are taking any ergot medications