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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Collaborator: Ministry of Health, Fiji
• Treatments: Azithromycin

Criteria

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