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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinded, randomized, placebo-controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Matched drug and placebo

Study Groups

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Azithromycin

A single 2g dose of Azithromycin

Group Type EXPERIMENTAL

Azithromycin 500 mg Oral Tablet x 4

Intervention Type DRUG

A single prophylactic dose of antibiotic given during labour

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Matching Placebo

Interventions

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Azithromycin 500 mg Oral Tablet x 4

A single prophylactic dose of antibiotic given during labour

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No