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

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ClinicalTrials.gov Identifier: NCT05429541
Recruitment Status : Recruiting
First Posted : June 23, 2022
Last Update Posted : August 7, 2023
Sponsor:
Collaborators:
International Islamic University Malaysia
Universiti Putra Malaysia
University of Southampton
Merck Sharp & Dohme LLC
Hospital Serdang
Information provided by (Responsible Party):
Lokman Hakim Sulaiman, MD, International Medical University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Streptococcus Pneumonia Otitis Media

Detailed 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
Study Design
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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.
Actual Study Start Date : April 5, 2023
Estimated Primary Completion Date : April 5, 2024
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Otitis Media (OM) Case Group

Case definition:

  1. Acute otitis media (AOM)

    AOM will be diagnosed by pneumatic otoscopy by validated otoscopists, when children with acute onset of otalgia had tympanic membranes (TMs) that were:

    1. bulging or full; and
    2. a cloudy or purulent effusion was observed, or the TM was completely opacified; and
    3. TM mobility was reduced or absent

  2. Otitis media with effusion (OME)

    Collection of fluid within the middle ear without signs of acute inflammation, fever or otorrhea. Otoscopic findings include:

    1. dull tympanic membrane (TM)
    2. retraction of TM
    3. fluid level or air bubble
    4. TM colour change
    5. restricted TM mobility with pneumatic otoscopy
  3. Chronic suppurative otitis media (CSOM)

Otoscopic findings:

  1. Perforated TM
  2. Mucopurulent discharge


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of Streptococcus pneumoniae (Spn) nasopharyngeal (NP) carriage among young children with OM (AOM/OME/CSOM). [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Serotype distribution of Streptococcus pneumoniae (Spn) among young children with OM (AOM/OME/CSOM). [ Time Frame: 12 months ]
    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.


Biospecimen Retention:   Samples With DNA
Middle ear fluid (MEF) sample and nasopharyngeal swab for cases aged 5 years and below will be cultured and Streptococcus Pneumoniae (Spn) isolates will be inoculated for DNA extraction.

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children meeting the inclusion criteria, attending general practitioner clinics, the outpatient department or admitted as hospital inpatients in sentinel teaching hospital sites (International Islamic University Malaysia, Universiti Putra Malaysia and Hospital Serdang). Male and female patients from the three major ethnic groups (Malay, Chinese, and Indian) will be recruited from each sentinel site.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429541


Contacts
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Contact: Nur Alia Johari, PhD +60 12 234 5651 NurAliaJohari@imu.edu.my
Contact: Nurul Hanis Ramzi, PhD +60 17 339 6532 nurulhanis@imu.edu.my

Locations
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Malaysia
Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia Recruiting
Kuantan, Pahang, Malaysia, 57000
Contact: Zamzil Amin Ash'ari, MBBS       zamzilamin@iium.edu.my   
Contact: Norhidayah Kamarudin, MBBS       norhidayahkamarudin@iium.edu.my;   
Principal Investigator: Ailin Razali, MBBS         
Sub-Investigator: Zamzil Amin Ash'ari, MBBS         
Sub-Investigator: Norhidayah Kamarudin, MBBS         
Universiti Putra Malaysia Recruiting
Serdang, Seri Kembangan, Malaysia, 43400
Contact: Atiqah Farah Zakaria, MBBS       atiqahfarah@gmail.com   
Contact: Saraiza Abu Bakar, MBBS       drsaraiza@yahoo.com   
Principal Investigator: Atiqah Farah Zakaria, MBBS         
Sub-Investigator: Saraiza Abu Bakar, MBBS         
Sponsors and Collaborators
International Medical University
International Islamic University Malaysia
Universiti Putra Malaysia
University of Southampton
Merck Sharp & Dohme LLC
Hospital Serdang
Investigators
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Principal Investigator: Lokman Hakim Sulaiman, PhD International Medical University
More Information
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Publications:
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.

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Responsible Party: Lokman Hakim Sulaiman, MD, Deputy Vice Chancellor, Research, International Medical University
ClinicalTrials.gov Identifier: NCT05429541    
Other Study ID Numbers: MISP #61353
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: August 7, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Otitis
Otitis Media
Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
 Ear Diseases
Otorhinolaryngologic Diseases
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Pneumonia, Bacterial