Pneumococcal Carriage, Serotypes, and Antibiotic Resistance in Malaysian Children: A Multi-Centre Study

NCT07545876 | Recruiting

• 2 other identifiers: 4.12/JCM-322/2025100064489
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this observational study is to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of nasopharyngeal carriage of Streptococcus pneumoniae in Malaysian children aged ≤5 years following the implementation of pneumococcal conjugate vaccines (PCVs). The study focuses on healthy and mildly symptomatic male and female children aged 0-60 months recruited from urban and semi-urban settings in Kuala Lumpur, Selangor, and Negeri Sembilan. The main questions it aims to answer are:

1. 1.What is the overall and age-specific prevalence of nasopharyngeal pneumococcal carriage among children aged ≤5 years in Malaysia?
2. 2.What are the circulating serotypes and antimicrobial resistance (AMR) profiles of pneumococcal isolates, and how are they associated with vaccination status and PCV valency coverage?
3. 3.Undergo a nasopharyngeal swab collection for pneumococcal detection.
4. 4.Provide demographic and vaccination history information through a standardised case report form completed with parental/guardian consent.
5. 5.Have their samples analysed using bacterial culture, antimicrobial susceptibility testing, and whole-genome sequencing (WGS) for serotyping and resistance profiling.

Conditions

Nasopharyngeal Carriage of Streptococcus Pneumoniae

Keywords

Streptococcus pneumoniae; nasopharyngeal carriage

Outcome Measures

Primary Outcomes (1)

• Prevalence of Streptococcus pneumoniae (Spn) nasopharyngeal carriage among children aged ≤5 years.

  The presence or absence of nasopharyngeal pneumococcal carriage will be determined using standard bacteriological culture methods. Confirmed S. pneumoniae isolates will be processed for DNA extraction, and the prevalence will be calculated as the proportion of children carrying the bacteria within the total sampled population of 600.

  18 months

Secondary Outcomes (1)

• Serotype distribution and Antimicrobial Resistance (AMR) profiles of Streptococcus pneumoniae (Spn) isolates

  18 months

Study Arms (1)

Pneumococcal Carriage Group

A single cohort of 600 children aged 0 to 60 months (≤5 years) recruited from urban and semi-urban community settings in Kuala Lumpur, Selangor, and Negeri Sembilan. This group includes healthy children and those with mild, self-limiting symptoms attending daycare centres, outpatient paediatric clinics, and community healthcare facilities. All participants will undergo a one-time nasopharyngeal swab collection to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of Streptococcus pneumoniae carriage.

Eligibility Criteria

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

Study Population

All children meeting the inclusion criteria, attending GP clinics, the outpatient department or admitted as hospital inpatients in sentinel teaching hospital sites. Male and female patients from the three major ethnic groups (Malay, Chinese, and Indian) will be recruited from each sentinel site.

You may qualify if:

• Children aged ≤5 years (0-60 months)
• Hemodynamically stable at the time of sampling
• Parent/guardian provides written informed consent
• Resident in Malaysia for at least 3 months prior to enrolment

You may not qualify if:

• Current or recent antibiotic use within the last 30 days
• Known to have an immunodeficiency or currently on chemotherapy, or post-transplant recipients or on high-dose steroids (defined as \>20mg/day or 2mg/kg/day of Prednisolone for 2 weeks or more)
• Has nasal surgery
• Refusal of consent by parent or guardian

Sponsors & Collaborators

• IMU University, Malaysia: lead

Study Sites (4)

KMI Taman Desa Medical Centre

Kuala Lumpur, Kuala Lumpur, 58100, Malaysia

RECRUITING

CMH Specialist Hospital

Seremban, Negeri Sembilan, 70200, Malaysia

RECRUITING

Hospital Tuanku Jaafar

Seremban, Negeri Sembilan, 70300, Malaysia

RECRUITING

Avisena Women's & Children Specialist Hospital

Shah Alam, Selangor, 40000, Malaysia

RECRUITING

Related Publications (6)

• Adegbola RA, DeAntonio R, Hill PC, Roca A, Usuf E, Hoet B, Greenwood BM. Carriage of Streptococcus pneumoniae and other respiratory bacterial pathogens in low and lower-middle income countries: a systematic review and meta-analysis. PLoS One. 2014 Aug 1;9(8):e103293. doi: 10.1371/journal.pone.0103293. eCollection 2014.

  PMID: 25084351 BACKGROUND

• Bogaert D, van Belkum A, Sluijter M, Luijendijk A, de Groot R, Rumke HC, Verbrugh HA, Hermans PW. Colonisation by Streptococcus pneumoniae and Staphylococcus aureus in healthy children. Lancet. 2004 Jun 5;363(9424):1871-2. doi: 10.1016/S0140-6736(04)16357-5.

  PMID: 15183627 BACKGROUND

• Zakiyah N, Insani WN, Suwantika AA, van der Schans J, Postma MJ. Pneumococcal Vaccination for Children in Asian Countries: A Systematic Review of Economic Evaluation Studies. Vaccines (Basel). 2020 Jul 30;8(3):426. doi: 10.3390/vaccines8030426.

  PMID: 32751569 BACKGROUND

• Sallam M, Abbadi J, Natsheh A, Ababneh NA, Mahafzah A, Ozkaya Sahin G. Trends in Antimicrobial Drug Resistance of Streptococcus pneumoniae Isolates at Jordan University Hospital (2000(-)2018). Antibiotics (Basel). 2019 Apr 12;8(2):41. doi: 10.3390/antibiotics8020041.

  PMID: 31013803 BACKGROUND

• Siira L, Vestrheim DF, Winje BA, Caugant DA, Steens A. Antimicrobial susceptibility and clonality of Streptococcus pneumoniae isolates recovered from invasive disease cases during a period with changes in pneumococcal childhood vaccination, Norway, 2004-2016. Vaccine. 2020 Jul 22;38(34):5454-5463. doi: 10.1016/j.vaccine.2020.06.040. Epub 2020 Jun 30.

  PMID: 32616324 BACKGROUND

• Aspa J, Rajas O, de Castro FR. Pneumococcal antimicrobial resistance: therapeutic strategy and management in community-acquired pneumonia. Expert Opin Pharmacother. 2008 Feb;9(2):229-41. doi: 10.1517/14656566.9.2.229.

  PMID: 18201146 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab from children aged 5 years and below will be cultured and Streptococcus Pneumoniae (Spn) isolates will be inoculated for DNA extraction

Study Officials

• Nurul Hanis Ramzi

  IMU University, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurul Hanis Ramzi

CONTACT

+60173396532; nurulhanis@imu.edu.my

Erwin Khoo Jiayuan

CONTACT

+60123678175; jiayuan_khoo@imu.edu.my

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (4)