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

NCT04923035 | Unknown

• 1 other identifier: MISP #60200
• Study Type: observational
• Target: 1,010
• Locations: 1 country
• Sites: 3

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.

Conditions

Pneumonia, Pneumococcal; Pneumonia Childhood

Keywords

surveillance; polymerase chain reaction; whole-genome sequencing; pneumococcal urine antigen detection; correlation analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Streptococcus pneumoniae (SPN) detection in urine samples among young children

  24 months

Study Arms (2)

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: 1. cough and/or 2. difficulty/rapid breathing and/or 3. intercostal recession, 4. 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.

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This is a prospective case-control study in which all children aged 5 years and below with clinically diagnosed community-acquired pneumonia and healthy controls will be recruited at three study sites. As per assumptions of 95% confidence interval (CI), 80% power and detectable odds ratio (OR) of 1.5, The investigators estimate 164 cases and 164 healthy controls per each sentinel hospital site. Thus, the investigators aim to recruit a total of 500 confirmed pneumonia cases and 500 healthy controls for this study.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• IMU University, Malaysia: lead
• University of Malaya: collaborator
• Universiti Sains Malaysia: collaborator
• International Islamic University Malaysia: collaborator
• University of Southampton: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 57000, Malaysia

Location

Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia

Kuantan, Pahang, 57000, Malaysia

Location

Related Publications (3)

• 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 phased pneumococcal conjugate vaccine introduction in Mongolia using enhanced pneumonia surveillance and community carriage surveys: a study protocol for a prospective observational study and lessons learned. BMC Public Health. 2019 Mar 21;19(1):333. doi: 10.1186/s12889-019-6639-y.

  PMID: 30898094 RESULT

• 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/s41598-018-21837-5.

  PMID: 29472635 RESULT

• Ramzi NH, Hoong ATC, Johari NA, Nathan AM, Teh CSJ, Sulaiman NA, Ilias MI, Deris ZZ, Hazlan SNH, Nasir NSM, Bakar AA, Helmi MAM, Juhari WKW, Kamarudin N, Chong CW, Cleary DW, Clarke SC, Sulaiman LH. Multicentre case-control study of pneumococcal infections among children with pneumonia in Peninsular Malaysia (MY-Pneumo): a study protocol. BMC Public Health. 2024 Aug 20;24(1):2255. doi: 10.1186/s12889-024-19789-9.

  PMID: 39164673 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab and urine sample for cases and control aged 5 years and below. Nasopharyngeal swab will be cultured and Streptococcus Pneumoniae isolates will be inoculated for DNA extraction.

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lokman Hakim H Sulaiman, PhD

  IMU University, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Vice Chancellor Research & Director, Institute of Research, Development and Innovation (IRDI)

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 11, 2021
• Study Start: October 13, 2021
• Primary Completion: August 29, 2023
• Study Completion: December 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)