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

Pneumonia, Pneumococcal Clinical Trial

— MSIP PCV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04923035
• Other study ID #: MISP #60200
• Status: Active, not recruiting
• Start date: October 13, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

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 individual/child.

5. To estimate sensitivity and specificity for SPN serotypes detection in urine among children with pneumonia and IPD.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1010
• Est. completion date: December 2024
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia Childhood
• Pneumonia, Pneumococcal

Locations

Country	Name	City	State
Malaysia	Hospital Universiti Sains Malaysia	Kota Bharu	Kelantan
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Federal Territory Of Kuala Lumpur
Malaysia	Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia	Kuantan	Pahang

Sponsors (6)

Lead Sponsor	Collaborator
International Medical University	International Islamic University Malaysia, Merck Sharp & Dohme LLC, Universiti Sains Malaysia, University of Malaya, University of Southampton

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

Adetifa IMO, Adamu AL, Karani A, Waithaka M, Odeyemi KA, Okoromah CAN, Bello MM, Abubakar IS, Inem V, Scott JAG. Nasopharyngeal Pneumococcal Carriage in Nigeria: a two-site, population-based survey. Sci Rep. 2018 Feb 22;8(1):3509. doi: 10.1038/s41598-018- — View Citation

La Vincente SF, von Mollendorf C, Ulziibayar M, Satzke C, Dashtseren L, Fox KK, Dunne EM, Nguyen CD, de Campo J, de Campo M, Thomson H, Surenkhand G, Demberelsuren S, Bujinlkham S, Do LAH, Narangerel D, Cherian T, Mungun T, Mulholland EK. Evaluation of a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasopharyngeal (NP) pneumococcal carriages prevalence rate among young children	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.	24 months
Secondary	Streptococcus pneumoniae (SPN) detection in urine samples among young children	To evaluate the correlations between SPN isolates detected in NP carriage and urine sample from the same individual/child.	24 months