Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial
Introduction Infections are a leading cause of neonatal mortality globally and can be transmitted from mother-to-child vertically or horizontally. Fiji has higher rates of serious neonatal infections and infant skin and soft tissue infections (SSTIs) than high-income countries. Research from the Gam...
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e061157.full |
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| author | John Hart Eric Rafai Kim Mulholland Andrew Steer Emma Watts Stephanie Clark Catherine Satzke Fiona M Russell Eleanor F G Neal Kathryn Bright Cattram Duong Nguyen Casey L Pell Maeve Hume-Nixon Tupou Ratu James Fong Kelera Sakumeni Ilisapeci Tuibeqa |
| author_facet | John Hart Eric Rafai Kim Mulholland Andrew Steer Emma Watts Stephanie Clark Catherine Satzke Fiona M Russell Eleanor F G Neal Kathryn Bright Cattram Duong Nguyen Casey L Pell Maeve Hume-Nixon Tupou Ratu James Fong Kelera Sakumeni Ilisapeci Tuibeqa |
| author_sort | John Hart |
| collection | DOAJ |
| description | Introduction Infections are a leading cause of neonatal mortality globally and can be transmitted from mother-to-child vertically or horizontally. Fiji has higher rates of serious neonatal infections and infant skin and soft tissue infections (SSTIs) than high-income countries. Research from the Gambia found that a single dose of oral azithromycin in labour decreased bacterial carriage and infections in mothers and infants, particularly infant skin infections. The Bulabula MaPei clinical trial evaluates the safety and efficacy of a single dose of azithromycin in labour in reducing the incidence of maternal and infant SSTIs and other infections and the impact on bacterial carriage. It will also describe the effect of azithromycin on antimicrobial (AMR) resistance, the maternal and infant microbiome, and infant dysbiosis.Methods and analysis We are conducting a blinded, placebo-controlled randomised clinical trial administering 2 g of oral azithromycin, or placebo, given to healthy, pregnant women (≥18 years) in labour in Suva, Fiji. The primary outcome is the cumulative incidence of SSTIs in infants by 3 months of age. Secondary outcomes include the incidence of other infant and maternal infections, and safety and tolerability of azithromycin in mother and infant. Following informed consent, 2110 pregnant women will be randomised in a 1:1 ratio, with all study staff and participants masked to group allocation. Mother/infant pairs will be followed up for 12 months over six visits collecting clinical data on infections, antimicrobial use, safety and anthropometrics, in addition to nasopharyngeal, oropharyngeal, rectovaginal and vaginal swabs, maternal breastmilk and infant stool samples, in order to compare bacterial carriage, AMR rates and microbiome. Recruitment for Bulabula MaPei started in June 2019.Ethics and dissemination This trial was approved and is being conducted according to the protocol approved by The Royal Children’s Hospital Human Research Ethics Committee, Australia, and the Fiji National Health Research and Ethics Review Committee. The findings of this study will be disseminated in peer-reviewed journals and presented at conferences.Trial registration number NCT03925480. |
| format | Article |
| id | doaj-art-a74ceb551d844091aaa794dd04dfbf81 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a74ceb551d844091aaa794dd04dfbf812025-08-20T02:28:20ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-061157Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trialJohn Hart0Eric Rafai1Kim Mulholland2Andrew Steer3Emma Watts4Stephanie Clark5Catherine Satzke6Fiona M Russell7Eleanor F G Neal8Kathryn Bright9Cattram Duong Nguyen10Casey L Pell11Maeve Hume-Nixon12Tupou Ratu13James Fong14Kelera Sakumeni15Ilisapeci Tuibeqa16Asia-Pacific Health, Murdoch Children`s Research Institute, Parkville, Victoria, AustraliaMinistry of Health and Medical Services, Suva, FijiNew Vaccines, Murdoch Children`s Research Institute, Parkville, Victoria, AustraliaDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, AustraliaENT, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKDepartment of Paediatrics, Colonial War Memorial Hospital, Suva, FijiDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, AustraliaDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, AustraliaDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, AustraliaAsia-Pacific Health, Murdoch Children`s Research Institute, Parkville, Victoria, AustraliaDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, AustraliaTranslational Microbiology, Murdoch Children`s Research Institute, Parkville, Victoria, AustraliaDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, AustraliaAsia-Pacific Health, Murdoch Children`s Research Institute, Suva, FijiRepublic of Fiji Ministry of Health, Suva, Rewa, FijiMinistry of Health and Medical Services, Suva, FijiDepartment of Paediatrics, Colonial War Memorial Hospital, Suva, FijiIntroduction Infections are a leading cause of neonatal mortality globally and can be transmitted from mother-to-child vertically or horizontally. Fiji has higher rates of serious neonatal infections and infant skin and soft tissue infections (SSTIs) than high-income countries. Research from the Gambia found that a single dose of oral azithromycin in labour decreased bacterial carriage and infections in mothers and infants, particularly infant skin infections. The Bulabula MaPei clinical trial evaluates the safety and efficacy of a single dose of azithromycin in labour in reducing the incidence of maternal and infant SSTIs and other infections and the impact on bacterial carriage. It will also describe the effect of azithromycin on antimicrobial (AMR) resistance, the maternal and infant microbiome, and infant dysbiosis.Methods and analysis We are conducting a blinded, placebo-controlled randomised clinical trial administering 2 g of oral azithromycin, or placebo, given to healthy, pregnant women (≥18 years) in labour in Suva, Fiji. The primary outcome is the cumulative incidence of SSTIs in infants by 3 months of age. Secondary outcomes include the incidence of other infant and maternal infections, and safety and tolerability of azithromycin in mother and infant. Following informed consent, 2110 pregnant women will be randomised in a 1:1 ratio, with all study staff and participants masked to group allocation. Mother/infant pairs will be followed up for 12 months over six visits collecting clinical data on infections, antimicrobial use, safety and anthropometrics, in addition to nasopharyngeal, oropharyngeal, rectovaginal and vaginal swabs, maternal breastmilk and infant stool samples, in order to compare bacterial carriage, AMR rates and microbiome. Recruitment for Bulabula MaPei started in June 2019.Ethics and dissemination This trial was approved and is being conducted according to the protocol approved by The Royal Children’s Hospital Human Research Ethics Committee, Australia, and the Fiji National Health Research and Ethics Review Committee. The findings of this study will be disseminated in peer-reviewed journals and presented at conferences.Trial registration number NCT03925480.https://bmjopen.bmj.com/content/12/12/e061157.full |
| spellingShingle | John Hart Eric Rafai Kim Mulholland Andrew Steer Emma Watts Stephanie Clark Catherine Satzke Fiona M Russell Eleanor F G Neal Kathryn Bright Cattram Duong Nguyen Casey L Pell Maeve Hume-Nixon Tupou Ratu James Fong Kelera Sakumeni Ilisapeci Tuibeqa Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial BMJ Open |
| title | Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial |
| title_full | Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial |
| title_fullStr | Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial |
| title_full_unstemmed | Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial |
| title_short | Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial |
| title_sort | prevention of young infant infections using oral azithromycin in labour in fiji bulabula mapei study protocol of a randomised control trial |
| url | https://bmjopen.bmj.com/content/12/12/e061157.full |
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