Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.

Otitis Media Clinical Trial

— OM  

Official title:

Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429541
• Other study ID #: MISP #61353
• Status: Recruiting
• Start date: April 5, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2023
• Source: International Medical University
• Contact: Nur Alia Johari, PhD
• Phone: +60 12 234 5651
• Email: NurAliaJohari[@]imu.edu.my
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to conduct a multi-center prospective surveillance study focusing upon pneumococcal carriage and serotype epidemiology in patients with otitis media (OM).The data generated will be crucial especially as baseline data for future assessments on the long-term impacts of pneumococcal conjugate vaccine 10 (PCV10) coverage, compared to that of pneumococcal conjugate vaccine 13 (PCV13) that is being used in the majority of other countries. Pneumococcal carriage in patients with OM and serotype distribution will be assessed, including changes in antibiotic resistance. With the establishment of sentinel surveillance in the country, we hope to provide detailed data on the epidemiology of OM in Malaysia; working towards the development of a national surveillance programme for the monitoring of OM burden in the country.

Description:

Otitis media (OM) is a condition defined as an inflammation of the middle ear and is one of the most commonly diagnosed infections in children, especially amongst those aged below 5 years (1). By 3 years of age, approximately 80% of children have experienced at least one episode of acute otitis media (AOM) in developed countries. More than 700 million AOM cases are reported annually worldwide at an incidence rate of 10.8%, with Southeast Asia reporting a yearly incidence of 8.2% and disease burden varying substantially by geographical location (2). In Malaysia, based on data published from a population based survey (n=7,041) conducted by the Ministry of Health in 2005 (3),OM with effusion (OME) prevalence was found to be 2.9% amongst individuals all ages, of which 46.5% suffered from hearing loss. Amongst children, OME prevalence was 3.8% in those aged ≤17 years, 1.4% in 13-17 year olds and 2.3% in children ≤12 years of age. The survey also found that prevalence was higher in rural settings (3.2%) compared to urban settings (2.7%). These findings were in contrast to an earlier cross-sectional study based on 5 to 6 years olds from kindergartens in 1993 (n=1,097), where prevalence was 17.9% in the urban district of Kuala Lumpur compared to 9.5% in rural Kuala Selangor (4). AOM was found in Malaysia to have a negative impact on both parental and child quality of life (QoL), with significant indirect healthcare costs and thus substantial economic burden in the population (5).

Studies on the epidemiology of AOM, especially those reliant upon clinical diagnosis and following the uptake of pneumococcal conjugate vaccination (PCV) are few and far between. In Malaysia the prevalence of OME, as described above, has been reported although limited to specific settings and locations, with even fewer assessments on AOM prevalence. Immunisation programmes against Spn have an impact on carriage, and consequently the causative pathogen and infecting strains of Spn in OM infections. There has been a consistent observed association between PCV introduction and a decline of AOM infections caused by Spn. As Malaysia is one of the more recent countries to start the PCV National Immunisation Programme (NIP), this presents an excellent opportunity to begin surveillance on pneumococcal carriage and serotype distribution allowing for a detailed assessment of the epidemiology of OM in the country.

Specific Objectives

1. To determine the prevalence of Streptococcus pneumoniae (Spn) nasopharyngeal carriage among children 5 years of age and below with OM

2. To determine Spn serotypes in children diagnosed with OM

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 30, 2025
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

Inclusion Criteria:

Children aged =3 months and <5 years with clinically diagnosed AOM/CSOM whose parent/legal authorized representative (LAR) is willing to give consent on his/her behalf and attending general practitioner clinics, the ear, nose and throat (ENT) outpatient's department or admitted as a hospital inpatient at hospital sites.

Exclusion Criteria:

Any child aged =3 months and <5 years old

• who does not meet the case definition

• whose parent/guardian does not give consent on his/her behalf.

• who had nasal surgery,

• who has chronic respiratory diseases (including asthma) and cardiac condition

• with tympanostomy tubes

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Pneumonia, Pneumococcal
• Streptococcus Pneumonia

Locations

Country	Name	City	State
Malaysia	Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia	Kuantan	Pahang
Malaysia	Universiti Putra Malaysia	Serdang	Seri Kembangan

Sponsors (6)

Lead Sponsor	Collaborator
International Medical University	Hospital Serdang, International Islamic University Malaysia, Merck Sharp & Dohme LLC, Universiti Putra Malaysia, University of Southampton

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

Crawford B, Hashim SS, Prepageran N, See GB, Meier G, Wada K, Coon C, Delgleize E, DeRosa M. Impact of Pediatric Acute Otitis Media on Child and Parental Quality of Life and Associated Productivity Loss in Malaysia: A Prospective Observational Study. Drugs Real World Outcomes. 2017 Mar;4(1):21-31. doi: 10.1007/s40801-016-0099-9. — View Citation

Institute For Public Health. Findings of the National Hearing and Ear Disorders Survey. Malaysia: Institute For Public Health, National Instiutes of Health, Ministry of Health Malaysia; 2009.

Mahadevan M, Navarro-Locsin G, Tan HK, Yamanaka N, Sonsuwan N, Wang PC, Dung NT, Restuti RD, Hashim SS, Vijayasekaran S. A review of the burden of disease due to otitis media in the Asia-Pacific. Int J Pediatr Otorhinolaryngol. 2012 May;76(5):623-35. doi: 10.1016/j.ijporl.2012.02.031. Epub 2012 Mar 8. — View Citation

Monasta L, Ronfani L, Marchetti F, Montico M, Vecchi Brumatti L, Bavcar A, Grasso D, Barbiero C, Tamburlini G. Burden of disease caused by otitis media: systematic review and global estimates. PLoS One. 2012;7(4):e36226. doi: 10.1371/journal.pone.0036226. Epub 2012 Apr 30. — View Citation

Saim A, Saim L, Saim S, Ruszymah BH, Sani A. Prevalence of otitis media with effusion amongst pre-school children in Malaysia. Int J Pediatr Otorhinolaryngol. 1997 Jul 18;41(1):21-8. doi: 10.1016/s0165-5876(97)00049-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Streptococcus pneumoniae (Spn) nasopharyngeal (NP) carriage among young children with OM (AOM/OME/CSOM).	The absence/presence of nasopharyngeal pneumococcal carriage will be tested using standard bacteriological methods and Streptococcus Pneumoniae (SPN) isolates will be inoculated for DNA extraction and tested by polymerase chain reaction (PCR) for pneumococcal carriage detection.	12 months
Secondary	Serotype distribution of Streptococcus pneumoniae (Spn) among young children with OM (AOM/OME/CSOM).	Spn isolates will be sequenced using whole-genome sequencing (WGS) platform (Illumina, UK) to determine the infecting serotype(s) among children with OM. Serotype and sequence type will be derived from the genomic data using a pipeline to identify the serotype from Illumina WGS reads for given references and multilocus sequence type respectively.	12 months