Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2021-06-01
Brief Title:
Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine PCV Implementation
Sponsor:
International Medical University
Organization:
International Medical University
Study Overview
Official Title:
Evaluating the Burden of Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine PCV Implementation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSIP PCV
Brief Summary:
The purpose of this research is to provide baseline surveillance of pneumonia in young children in Malaysia before and during the implementation of the pneumococcal conjugate vaccine PCV Pneumonia is a respiratory infection that can cause mild to life-threatening disease among all age groups but is the leading infectious cause of death among children globally The most common cause of pneumonia is infection with a bacteria called Streptococcus pneumoniae also known as pneumococcus Hence immunisation with a pneumococcal vaccine is an effective way to prevent pneumonia In Malaysia pneumococcal vaccination under the National Immunisation Programme NIP for children has since commenced in December 2020 comprising of 3 doses at four six and 15 months The routine use of PCV in children will contribute to reducing the burden of pneumococcal infections in the country especially severe infections The ongoing COVID-19 pandemic may also have implications on the pneumococcal serotype and clinical presentation of infections in the community
Detailed Description:
This study will be a multi-centre prospective case-control study and the recruitment of clinically diagnosed pneumonia patients and healthy controls aged 5 years and below will be conducted at the three university hospitals University Malaya Medical Centre UMMC Sultan Ahmad Shah Medical CentreInternational Islamic University Malaysia SASMECIIUM and Hospital University Sains Malaysia HUSM Subject recruitment and sample collection will be carried out for 24 months Informed consent and general questionnaire will be administrated by the on-site researchers Clinical samples will be taken according to approved protocol and local policy to include nasopharyngeal NP swab and urine sample NP swab in a transport medium will be store at -80C before shipment to the International Medical University IMU Advanced Microbiology Collaborative Research Laboratory AMCRL in Kuala Lumpur for polymerase chain reaction PCR analysis The data obtained may provide crucial data to support policy decisions on pneumococcal vaccination
Specific Objectives
1 To determine the prevalence of Streptococcus pneumoniae SPN nasopharyngeal NP carriage among children 5 years of age and below with pneumonia and invasive pneumonia disease IPD using polymerase chain reaction PCR analysis
2 To determine SPN serotypes in young children during the coronavirus disease 2019 COVID-19 pandemic by whole-genome sequencing analysis
3 To identify potential changes in clinical presentation and severity of pneumococcal infection in young children during the COVID-19 pandemic
4 To evaluate the correlations between SPN serotypes detected in NP carriage and urine sample from the same individualchild
5 To estimate sensitivity and specificity for SPN serotypes detection in urine among children with pneumonia and IPD
Specific Objectives
1 To determine the prevalence of Streptococcus pneumoniae SPN nasopharyngeal NP carriage among children 5 years of age and below with pneumonia and invasive pneumonia disease IPD using polymerase chain reaction PCR analysis
2 To determine SPN serotypes in young children during the coronavirus disease 2019 COVID-19 pandemic by whole-genome sequencing analysis
3 To identify potential changes in clinical presentation and severity of pneumococcal infection in young children during the COVID-19 pandemic
4 To evaluate the correlations between SPN serotypes detected in NP carriage and urine sample from the same individualchild
5 To estimate sensitivity and specificity for SPN serotypes detection in urine among children with pneumonia and IPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None