Clinical trial NCT05429541: Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.
Official title: Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Streptococcus Pneumonia
Otitis Media
Lead sponsor: International Medical University
Sponsor class: OTHER
Collaborators: name: International Islamic University Malaysia
name: Universiti Putra Malaysia
name: University of Southampton
name: Merck Sharp & Dohme LLC
name: Hospital Serdang
First posted: 2022-06-23
Enrollment: 360
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: Prevalence of Streptococcus pneumoniae (Spn) nasopharyngeal (NP) carriage among young children with OM (AOM/OME/CSOM).
timeFrame: 12 months
Secondary outcomes:
measure: Serotype distribution of Streptococcus pneumoniae (Spn) among young children with OM (AOM/OME/CSOM).
timeFrame: 12 months
Other outcomes:
Locations:
city: Kuantan
country: Malaysia
facility: Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia
state: Pahang
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Seri Kembangan
Study officials:
affiliation: International Medical University
name: Lokman Hakim Sulaiman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
citation: 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.