MSIP PCV: Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine (PCV) Implementation

Sponsor

International Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04923035

Collaborator

University of Malaya (Other), Universiti Sains Malaysia (Other), International Islamic University Malaysia (Other), University of Southampton (Other), Merck Sharp & Dohme LLC (Industry)

1,000

Enrollment

Locations

31.6

Anticipated Duration (Months)

333.3

Patients Per Site

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumococcal Pneumonia Childhood

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 Centre@International Islamic University Malaysia (SASMEC@IIUM) 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 -80°C 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

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.
To determine SPN serotypes in young children during the coronavirus disease 2019 (COVID-19) pandemic by whole-genome sequencing analysis.
To identify potential changes in clinical presentation and severity of pneumococcal infection in young children during the COVID-19 pandemic.
To evaluate the correlations between SPN serotypes detected in NP carriage and urine sample from the same individual/child.
To estimate sensitivity and specificity for SPN serotypes detection in urine among children with pneumonia and IPD.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluating the Burden of Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine (PCV) Implementation

Actual Study Start Date :

Oct 13, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Case Children aged 5 years and below with clinically diagnosed pneumonia and attending the outpatient's department or admitted as a hospital inpatient at three sentinel sites. Pneumonia. Suspected pneumonia cases will be identified by a family physician or paediatrician based on medical history and clinical symptoms. Pneumonia is defined as (WHO Fact Sheet 2019) patient with history of: cough and/or difficulty/rapid breathing and/or intercostal recession, with or without fever. and supported by chest x-ray findings.
Control Healthy children aged 5 years and below without any intercurrent respiratory illness and who is in good health as determined by a brief medical history and/or clinical judgement of the investigator whose parent/LAR is willing and able to give informed consent.

Arm

Intervention/Treatment

Case

Children aged 5 years and below with clinically diagnosed pneumonia and attending the outpatient's department or admitted as a hospital inpatient at three sentinel sites. Pneumonia. Suspected pneumonia cases will be identified by a family physician or paediatrician based on medical history and clinical symptoms. Pneumonia is defined as (WHO Fact Sheet 2019) patient with history of: cough and/or difficulty/rapid breathing and/or intercostal recession, with or without fever. and supported by chest x-ray findings.

Control

Healthy children aged 5 years and below without any intercurrent respiratory illness and who is in good health as determined by a brief medical history and/or clinical judgement of the investigator whose parent/LAR is willing and able to give informed consent.

Outcome Measures

Primary Outcome Measures

Nasopharyngeal (NP) pneumococcal carriages prevalence rate among young children [24 months]
The absence/presence of nasopharyngeal pneumococcal carriages will be tested using standard bacteriological methods and Streptococcus Pneumoniae (SPN) isolates will be inoculated for DNA extraction and further tested by polymerase chain reaction (PCR) for pneumococcal carriage detection.

Secondary Outcome Measures

Streptococcus pneumoniae (SPN) detection in urine samples among young children [24 months]
To evaluate the correlations between SPN isolates detected in NP carriage and urine sample from the same individual/child.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Any child aged 5 years and below who meets the case and control definition and whose parent/legal authorized representative (LAR) is willing to give consent on his/her behalf.

Exclusion Criteria:

who does not meet the case and control definition
whose parent/guardian does not give consent on his/her behalf
who has nasal surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Malaya Medical Centre	Kuala Lumpur	Federal Territory Of Kuala Lumpur	Malaysia	57000
2	Hospital Universiti Sains Malaysia	Kota Bharu	Kelantan	Malaysia	16150
3	Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia	Kuantan	Pahang	Malaysia	57000