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

NCT ID: NCT05429541

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2025-09-30

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.

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

Conditions

Streptococcus Pneumonia; Otitis Media

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Islamic University Malaysia

OTHER

Sponsor Role: collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Hospital Serdang

UNKNOWN

Sponsor Role: collaborator

IMU University, Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Lokman Hakim Sulaiman, MD

Deputy Vice Chancellor, Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lokman Hakim Sulaiman, PhD

Role: PRINCIPAL_INVESTIGATOR

IMU University, Malaysia

Locations

Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia

Kuantan, Pahang, Malaysia

Site Status: RECRUITING

Universiti Putra Malaysia

Serdang, Seri Kembangan, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Nur Alia Johari, PhD

Role: CONTACT

NurAliaJohari@imu.edu.my

+60 12 234 5651

Nurul Hanis Ramzi, PhD

Role: CONTACT

nurulhanis@imu.edu.my

+60 17 339 6532

Facility Contacts

Zamzil Amin Ash'ari, MBBS

Role: primary

zamzilamin@iium.edu.my

Norhidayah Kamarudin, MBBS

Role: backup

norhidayahkamarudin@iium.edu.my;

Atiqah Farah Zakaria, MBBS

Role: primary

atiqahfarah@gmail.com

Saraiza Abu Bakar, MBBS

Role: backup

drsaraiza@yahoo.com

References

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.

Reference Type: BACKGROUND

PMID: 22404948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22558393 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 9279632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27888477 (View on PubMed)

Other Identifiers

MISP #61353

Identifier Type: -

Identifier Source: org_study_id