Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol

Background S. pneumoniae (SPN) is the most common cause of pneumonia. The disease can be effectively prevented through immunisation. Since December 2020, the Malaysian Government has included the 10-valent pneumococcal conjugate vaccine (PCV10) for all infants born on or after 1 January 2020 as pa...

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Main Authors: Ramzi, Nurul Hanis, Hoong, Andrew Tan Chun, Johari, Nur Alia, Nathan, Anna Marie, Teh, Cindy Shuan Ju, Sulaiman, Norhayati Aida, Ilias, Mohamad Ikram, Deris, Zakuan Zainy, Hazlan, Siti Nur Haidar, Mohamad Nasir, Nur Syafiqah, Abu Bakar, Asrar, Muhd Helmi, Muhd Alwi, Wan Juhari, Wan Khairunnisa, Kamarudin, Norhidayah, Chong, Chun Wie, Cleary, David W., Clarke, Stuart C., Sulaiman, Lokman Hakim
Format: Article
Language:English
English
Published: Springer Nature 2024
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Online Access:http://irep.iium.edu.my/114114/7/114114_Multicentre%20case%E2%80%93control%20study%20of%20pneumococcal%20infections.pdf
http://irep.iium.edu.my/114114/13/114114_Multicentre%20case%E2%80%93control%20study%20of%20pneumococcal%20infections_Scopus.pdf
http://irep.iium.edu.my/114114/
https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-19789-9
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id my.iium.irep.114114
record_format dspace
institution Universiti Islam Antarabangsa Malaysia
building IIUM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider International Islamic University Malaysia
content_source IIUM Repository (IREP)
url_provider http://irep.iium.edu.my/
language English
English
topic RA643 Communicable Diseases and Public Health
RJ Pediatrics
RJ370 Disease of children
spellingShingle RA643 Communicable Diseases and Public Health
RJ Pediatrics
RJ370 Disease of children
Ramzi, Nurul Hanis
Hoong, Andrew Tan Chun
Johari, Nur Alia
Nathan, Anna Marie
Teh, Cindy Shuan Ju
Sulaiman, Norhayati Aida
Ilias, Mohamad Ikram
Deris, Zakuan Zainy
Hazlan, Siti Nur Haidar
Mohamad Nasir, Nur Syafiqah
Abu Bakar, Asrar
Muhd Helmi, Muhd Alwi
Wan Juhari, Wan Khairunnisa
Kamarudin, Norhidayah
Chong, Chun Wie
Cleary, David W.
Clarke, Stuart C.
Sulaiman, Lokman Hakim
Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol
description Background S. pneumoniae (SPN) is the most common cause of pneumonia. The disease can be effectively prevented through immunisation. Since December 2020, the Malaysian Government has included the 10-valent pneumococcal conjugate vaccine (PCV10) for all infants born on or after 1 January 2020 as part of the National Immunisation Programme (NIP). However, the epidemiology of pneumonia remains poorly understood. To fill the knowledge gap, we established a multicentre surveillance study to understand the burden of pneumococcal pneumonia among young children in Peninsular Malaysia. Methods MY-Pneumo is a multicentre prospective case–control study conducted in three sentinel sites located in three different states of Peninsular Malaysia – Kuala Lumpur, Pahang, and Kelantan. A cohort of at least 500 incident cases and 500 controls is enrolled beginning in October 2021 and matched for age. Cases are hospitalised children <5 years with radiologically confirmed pneumonia, and the controls are children without any features suggestive of pneumonia. Clinical samples, including nasopharyngeal swabs (NPS) and urine, are collected according to the study protocol. Biological fluids such as blood, cerebrospinal fluid (CSF) and pleural fluid are obtained from invasive pneumonia disease (IPD) patients, if available. All children are tested for SPN using polymerase chain reaction (PCR) and pneumococcal urine antigen test (PUAT) using BinaxNow. Discussion Surveillance data, including carriage rate, serotype variations and the phylogeny data structure of SPN among young children in Malaysia during PCV implementation, will be generated from this study. Trends and patterns of pneumococcal serotypes by different regions are important for targeted public health strategies. Our data will provide baseline information for estimating the impact of PCV10 implementation and will influence policymakers’ decisions regarding the upgrade from PCV10 to a higher-valency conjugate vaccine in Malaysia. Trial registration This project was registered at ClinicalTrials.gov (NCT04923035) on 2021, June 11. The study protocol was approved by the International Medical University Joint-Committee on Research & Ethics (4.15/JCM-216/2021) and the Institutional Review Board at sentinel sites (USM/JEPeM/21020190, IREC 2021–114, MREC ID No: 20211289769) and University of Southampton’s Ethics and Research Governance (ERGo II 64844).
format Article
author Ramzi, Nurul Hanis
Hoong, Andrew Tan Chun
Johari, Nur Alia
Nathan, Anna Marie
Teh, Cindy Shuan Ju
Sulaiman, Norhayati Aida
Ilias, Mohamad Ikram
Deris, Zakuan Zainy
Hazlan, Siti Nur Haidar
Mohamad Nasir, Nur Syafiqah
Abu Bakar, Asrar
Muhd Helmi, Muhd Alwi
Wan Juhari, Wan Khairunnisa
Kamarudin, Norhidayah
Chong, Chun Wie
Cleary, David W.
Clarke, Stuart C.
Sulaiman, Lokman Hakim
author_facet Ramzi, Nurul Hanis
Hoong, Andrew Tan Chun
Johari, Nur Alia
Nathan, Anna Marie
Teh, Cindy Shuan Ju
Sulaiman, Norhayati Aida
Ilias, Mohamad Ikram
Deris, Zakuan Zainy
Hazlan, Siti Nur Haidar
Mohamad Nasir, Nur Syafiqah
Abu Bakar, Asrar
Muhd Helmi, Muhd Alwi
Wan Juhari, Wan Khairunnisa
Kamarudin, Norhidayah
Chong, Chun Wie
Cleary, David W.
Clarke, Stuart C.
Sulaiman, Lokman Hakim
author_sort Ramzi, Nurul Hanis
title Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol
title_short Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol
title_full Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol
title_fullStr Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol
title_full_unstemmed Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol
title_sort multicentre case–control study of pneumococcal infections among children with pneumonia in peninsular malaysia (my-pneumo): a study protocol
publisher Springer Nature
publishDate 2024
url http://irep.iium.edu.my/114114/7/114114_Multicentre%20case%E2%80%93control%20study%20of%20pneumococcal%20infections.pdf
http://irep.iium.edu.my/114114/13/114114_Multicentre%20case%E2%80%93control%20study%20of%20pneumococcal%20infections_Scopus.pdf
http://irep.iium.edu.my/114114/
https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-19789-9
_version_ 1809136378659733504
spelling my.iium.irep.1141142024-09-02T00:52:50Z http://irep.iium.edu.my/114114/ Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol Ramzi, Nurul Hanis Hoong, Andrew Tan Chun Johari, Nur Alia Nathan, Anna Marie Teh, Cindy Shuan Ju Sulaiman, Norhayati Aida Ilias, Mohamad Ikram Deris, Zakuan Zainy Hazlan, Siti Nur Haidar Mohamad Nasir, Nur Syafiqah Abu Bakar, Asrar Muhd Helmi, Muhd Alwi Wan Juhari, Wan Khairunnisa Kamarudin, Norhidayah Chong, Chun Wie Cleary, David W. Clarke, Stuart C. Sulaiman, Lokman Hakim RA643 Communicable Diseases and Public Health RJ Pediatrics RJ370 Disease of children Background S. pneumoniae (SPN) is the most common cause of pneumonia. The disease can be effectively prevented through immunisation. Since December 2020, the Malaysian Government has included the 10-valent pneumococcal conjugate vaccine (PCV10) for all infants born on or after 1 January 2020 as part of the National Immunisation Programme (NIP). However, the epidemiology of pneumonia remains poorly understood. To fill the knowledge gap, we established a multicentre surveillance study to understand the burden of pneumococcal pneumonia among young children in Peninsular Malaysia. Methods MY-Pneumo is a multicentre prospective case–control study conducted in three sentinel sites located in three different states of Peninsular Malaysia – Kuala Lumpur, Pahang, and Kelantan. A cohort of at least 500 incident cases and 500 controls is enrolled beginning in October 2021 and matched for age. Cases are hospitalised children <5 years with radiologically confirmed pneumonia, and the controls are children without any features suggestive of pneumonia. Clinical samples, including nasopharyngeal swabs (NPS) and urine, are collected according to the study protocol. Biological fluids such as blood, cerebrospinal fluid (CSF) and pleural fluid are obtained from invasive pneumonia disease (IPD) patients, if available. All children are tested for SPN using polymerase chain reaction (PCR) and pneumococcal urine antigen test (PUAT) using BinaxNow. Discussion Surveillance data, including carriage rate, serotype variations and the phylogeny data structure of SPN among young children in Malaysia during PCV implementation, will be generated from this study. Trends and patterns of pneumococcal serotypes by different regions are important for targeted public health strategies. Our data will provide baseline information for estimating the impact of PCV10 implementation and will influence policymakers’ decisions regarding the upgrade from PCV10 to a higher-valency conjugate vaccine in Malaysia. Trial registration This project was registered at ClinicalTrials.gov (NCT04923035) on 2021, June 11. The study protocol was approved by the International Medical University Joint-Committee on Research & Ethics (4.15/JCM-216/2021) and the Institutional Review Board at sentinel sites (USM/JEPeM/21020190, IREC 2021–114, MREC ID No: 20211289769) and University of Southampton’s Ethics and Research Governance (ERGo II 64844). Springer Nature 2024-12 Article PeerReviewed application/pdf en http://irep.iium.edu.my/114114/7/114114_Multicentre%20case%E2%80%93control%20study%20of%20pneumococcal%20infections.pdf application/pdf en http://irep.iium.edu.my/114114/13/114114_Multicentre%20case%E2%80%93control%20study%20of%20pneumococcal%20infections_Scopus.pdf Ramzi, Nurul Hanis and Hoong, Andrew Tan Chun and Johari, Nur Alia and Nathan, Anna Marie and Teh, Cindy Shuan Ju and Sulaiman, Norhayati Aida and Ilias, Mohamad Ikram and Deris, Zakuan Zainy and Hazlan, Siti Nur Haidar and Mohamad Nasir, Nur Syafiqah and Abu Bakar, Asrar and Muhd Helmi, Muhd Alwi and Wan Juhari, Wan Khairunnisa and Kamarudin, Norhidayah and Chong, Chun Wie and Cleary, David W. and Clarke, Stuart C. and Sulaiman, Lokman Hakim (2024) Multicentre case–control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol. BMC Public Health, 24 (1). E-ISSN 1471-2458 https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-19789-9 10.1186/s12889-024-19789-9
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