Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial
Introduction Acute lower respiratory infections (ALRIs) remain the leading causes of repeated hospitalisations among young disadvantaged Australian and New Zealand First Nations and Timorese children. Severe (hospitalised) and recurrent ALRIs in the first years of life are associated with future chr...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-02-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/2/e097455.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832088069493227520 |
|---|---|
| author | Anne B Chang Keith Grimwood Yuejen Zhao Gabrielle B McCallum Catherine A Byrnes Heidi Smith-Vaughan Peter S Morris Christine Connors Adrian Trenholme Shirley Lawrence Joshua Francis Kobi L Schutz Mark D Chatfield Nevio Sarmento Robyn L. Marsh Emily R Bowden Nicholas Fancourt Adriano Vieira Kim M Hare Dennis Bonney Felicity Marwick Bronwyn Karvonen Carolyn Maclennan Milena Santos Lay Endang Soares da Silva |
| author_facet | Anne B Chang Keith Grimwood Yuejen Zhao Gabrielle B McCallum Catherine A Byrnes Heidi Smith-Vaughan Peter S Morris Christine Connors Adrian Trenholme Shirley Lawrence Joshua Francis Kobi L Schutz Mark D Chatfield Nevio Sarmento Robyn L. Marsh Emily R Bowden Nicholas Fancourt Adriano Vieira Kim M Hare Dennis Bonney Felicity Marwick Bronwyn Karvonen Carolyn Maclennan Milena Santos Lay Endang Soares da Silva |
| author_sort | Anne B Chang |
| collection | DOAJ |
| description | Introduction Acute lower respiratory infections (ALRIs) remain the leading causes of repeated hospitalisations among young disadvantaged Australian and New Zealand First Nations and Timorese children. Severe (hospitalised) and recurrent ALRIs in the first years of life are associated with future chronic lung diseases (eg, bronchiectasis) and impaired lung function. Despite the high burden and long-term consequences of severe ALRIs, clinical, evidence-based and feasible interventions (other than vaccine programmes) that reduce ALRI hospitalisations in children are limited. This randomised controlled trial (RCT) will address this unmet need by trialling a commonly prescribed macrolide antibiotic (azithromycin) for 6–12 months. Long-term azithromycin was chosen as it reduces ALRI rates by 50% in Australian and New Zealand First Nations children with chronic suppurative lung disease or bronchiectasis. The aim of this multicentre, international, double-blind, placebo-containing RCT is to determine whether 6–12 months of weekly azithromycin administered to Australian and New Zealand First Nations and Timorese children after their hospitalisation with an ALRI reduces subsequent ALRIs compared with placebo. Our primary hypothesis is that children receiving long-term azithromycin will have fewer medically attended ALRIs over the intervention period than those receiving placebo.Methods and analysis We will recruit 160 Australian and New Zealand First Nations and Timorese children aged <2 years to a parallel, superiority RCT across four hospitals from three countries (Australia, New Zealand and Timor-Leste). The primary outcome is the rate of medically attended ALRIs during the intervention period. The secondary outcomes are the rates and proportions of children with ALRI-related hospitalisation, chronic symptoms/signs suggestive of underlying chronic suppurative lung disease or bronchiectasis, serious adverse events, and antimicrobial resistance in the upper airways, and cost-effectiveness analyses.Ethics and dissemination The Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Health Research (Australia), Health and Disability Ethics Committee (New Zealand) and the Institute National of Health-Research Technical Committee (Timor-Leste) approved this study. The study outcomes will be disseminated to academic and medical communities via international peer-reviewed journals and conference presentations, and findings reported to health departments and consumer-based health organisations.Clinical trial registration Australia New Zealand Clinical Trial Registry ACTRN12619000456156. |
| format | Article |
| id | doaj-art-bbfa6ff621724786964fb182fd0f3c47 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-bbfa6ff621724786964fb182fd0f3c472025-02-06T03:00:14ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-097455Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trialAnne B Chang0Keith Grimwood1Yuejen Zhao2Gabrielle B McCallum3Catherine A Byrnes4Heidi Smith-Vaughan5Peter S Morris6Christine Connors7Adrian Trenholme8Shirley Lawrence9Joshua Francis10Kobi L Schutz11Mark D Chatfield12Nevio Sarmento13Robyn L. Marsh14Emily R Bowden15Nicholas Fancourt16Adriano Vieira17Kim M Hare18Dennis Bonney19Felicity Marwick20Bronwyn Karvonen21Carolyn Maclennan22Milena Santos Lay23Endang Soares da Silva24The Australian Centre for Health Services Innovations, Queensland University of Technology, Brisbane, Queensland, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaHealth Statistics and Informatics, Northern Territory Department of Health, Casuarina, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaDepartment of Pediatrics, Starship Children`s Health, Auckland, Auckland, New ZealandChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaTop End Health Services, Northern Territory Department of Health, Casuarina, Northern Territory, AustraliaDepartment of Paediatrics, Middlemore Hospital, Auckland, Auckland, New ZealandDepartment of Paediatrics, Middlemore Hospital, Auckland, Auckland, New ZealandGlobal and Tropical Health, Menzies School of Health Research, Casuarina, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaGlobal and Tropical Health, Menzies School of Health Research, Casuarina, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaNorthern Territory Department of Health, Casuarina, Northern Territory, AustraliaSchool Nurse, St Francis of the Fields Primary School, Strathfieldsaye, Victoria, AustraliaChild and Maternal Health, Menzies School of Health Research, Darwin, Northern Territory, AustraliaDepartment of Paediatrics, Guido Valadares National Hospital, Dili, Timor-LestePartnership for Human Development, Dili, Timor-LesteIntroduction Acute lower respiratory infections (ALRIs) remain the leading causes of repeated hospitalisations among young disadvantaged Australian and New Zealand First Nations and Timorese children. Severe (hospitalised) and recurrent ALRIs in the first years of life are associated with future chronic lung diseases (eg, bronchiectasis) and impaired lung function. Despite the high burden and long-term consequences of severe ALRIs, clinical, evidence-based and feasible interventions (other than vaccine programmes) that reduce ALRI hospitalisations in children are limited. This randomised controlled trial (RCT) will address this unmet need by trialling a commonly prescribed macrolide antibiotic (azithromycin) for 6–12 months. Long-term azithromycin was chosen as it reduces ALRI rates by 50% in Australian and New Zealand First Nations children with chronic suppurative lung disease or bronchiectasis. The aim of this multicentre, international, double-blind, placebo-containing RCT is to determine whether 6–12 months of weekly azithromycin administered to Australian and New Zealand First Nations and Timorese children after their hospitalisation with an ALRI reduces subsequent ALRIs compared with placebo. Our primary hypothesis is that children receiving long-term azithromycin will have fewer medically attended ALRIs over the intervention period than those receiving placebo.Methods and analysis We will recruit 160 Australian and New Zealand First Nations and Timorese children aged <2 years to a parallel, superiority RCT across four hospitals from three countries (Australia, New Zealand and Timor-Leste). The primary outcome is the rate of medically attended ALRIs during the intervention period. The secondary outcomes are the rates and proportions of children with ALRI-related hospitalisation, chronic symptoms/signs suggestive of underlying chronic suppurative lung disease or bronchiectasis, serious adverse events, and antimicrobial resistance in the upper airways, and cost-effectiveness analyses.Ethics and dissemination The Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Health Research (Australia), Health and Disability Ethics Committee (New Zealand) and the Institute National of Health-Research Technical Committee (Timor-Leste) approved this study. The study outcomes will be disseminated to academic and medical communities via international peer-reviewed journals and conference presentations, and findings reported to health departments and consumer-based health organisations.Clinical trial registration Australia New Zealand Clinical Trial Registry ACTRN12619000456156.https://bmjopen.bmj.com/content/15/2/e097455.full |
| spellingShingle | Anne B Chang Keith Grimwood Yuejen Zhao Gabrielle B McCallum Catherine A Byrnes Heidi Smith-Vaughan Peter S Morris Christine Connors Adrian Trenholme Shirley Lawrence Joshua Francis Kobi L Schutz Mark D Chatfield Nevio Sarmento Robyn L. Marsh Emily R Bowden Nicholas Fancourt Adriano Vieira Kim M Hare Dennis Bonney Felicity Marwick Bronwyn Karvonen Carolyn Maclennan Milena Santos Lay Endang Soares da Silva Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial BMJ Open |
| title | Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial |
| title_full | Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial |
| title_fullStr | Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial |
| title_full_unstemmed | Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial |
| title_short | Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial |
| title_sort | azithromycin to prevent acute lower respiratory infections among australian and new zealand first nations and timorese children petal trial study protocol for a multicentre international double blind randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/2/e097455.full |
| work_keys_str_mv | AT annebchang azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT keithgrimwood azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT yuejenzhao azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT gabriellebmccallum azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT catherineabyrnes azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT heidismithvaughan azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT petersmorris azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT christineconnors azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT adriantrenholme azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT shirleylawrence azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT joshuafrancis azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT kobilschutz azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT markdchatfield azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT neviosarmento azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT robynlmarsh azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT emilyrbowden azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT nicholasfancourt azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT adrianovieira azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT kimmhare azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT dennisbonney azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT felicitymarwick azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT bronwynkarvonen azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT carolynmaclennan azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT milenasantoslay azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial AT endangsoaresdasilva azithromycintopreventacutelowerrespiratoryinfectionsamongaustralianandnewzealandfirstnationsandtimoresechildrenpetaltrialstudyprotocolforamulticentreinternationaldoubleblindrandomisedcontrolledtrial |