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

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ClinicalTrials.gov Identifier: NCT03925480
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Ministry of Health, Fiji
Information provided by (Responsible Party):
Fiona Russell, 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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: Azithromycin 500 mg Oral Tablet x 4 Drug: Matching Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matched drug and placebo
Primary Purpose: Prevention
Official Title: Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL): a Blinded, Randomised, Placebo-controlled Trial
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azithromycin
A single 2g dose of Azithromycin
Drug: Azithromycin 500 mg Oral Tablet x 4
A single prophylactic dose of antibiotic given during labour

Placebo Comparator: Placebo
Matching Placebo
Drug: Matching Placebo
Matching Placebo




Primary Outcome Measures :
  1. Cumulative incidence of skin and soft tissue infection by 3 months of age in infants [ Time Frame: 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 :
  1. Cumulative incidence of skin and soft tissue infection, and other infections by 12 months of age in infants [ Time Frame: 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;

  2. Cumulative incidence of maternal infection by 6 weeks and 12 months post-delivery [ Time Frame: 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

  3. Cumulative incidence of antibiotic usage by 12 months in infants [ Time Frame: 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;

  4. Cumulative incidence of maternal antibiotic usage by 12 months post-delivery [ Time Frame: 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

  5. Number of infant participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1 [ Time Frame: 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.

  6. Number of maternal participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1 [ Time Frame: 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.

  7. 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 [ Time Frame: 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

  8. Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus with azithromycin nonsusceptibility cultured from impetigo swabs. [ Time Frame: 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

  9. Swab study outcome - Prevalence of bacterial carriage as assessed by real-time quantitative PCR (qPCR) [ Time Frame: 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

  10. Swab study outcome - Density of bacterial carriage as assessed by real-time quantitative PCR (qPCR) [ Time Frame: 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

  11. Swab study outcome - Risk of maternal carriage identified through qPCR of common organisms relevant to Sexually Transmitted Infections (STI) [ Time Frame: Delivery/birth to 12 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.

  12. Swab study outcome - Risk of antibiotic nonsusceptibility in culture isolates [ Time Frame: 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

  13. Swab study outcome - Effects of the intervention on the infant and maternal microbiome of specified body sites [ Time Frame: Delivery/birth to 12 months ]
    To compare the infant and maternal microbiome of specified body sites at key time points in the intervention and placebo groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 admission for delivery
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925480


Contacts
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Contact: Helen W Thomson, MSc +61 399366771 helen.thomson@mcri.edu.au
Contact: Kathryn Bright, BSc kathrynbright59@gmail.com

Locations
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Fiji
Colonial War Memorial Hospital and Mother and Child Health Clinics Recruiting
Suva, Central, Fiji
Contact: Felisita T Ratu, BSc       tupou.ratu@gmail.com   
Contact: Maeve Hume-Nixon, MBChB, MSc       maeve.humenixon@mcri.edu.au   
Principal Investigator: Maeve Hume-Nixon, MBChB, MSc         
Sponsors and Collaborators
Murdoch Childrens Research Institute
Ministry of Health, Fiji
Investigators
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Principal Investigator: Fiona M Russell, BMBS PhD Murdoch Childrens Research Institute

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Responsible Party: Fiona Russell, Professor, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT03925480     History of Changes
Other Study ID Numbers: HREC 38057
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The de-identified data set collected for this analysis of the PreYIAL trial will be available six months after publication of the primary outcome.

The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: From 6 months following publication of primary results for 15 years
Access Criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the DSMB must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections