NCT05429541

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

June 19, 2022

Last Update Submit

August 3, 2023

Conditions

Streptococcus PneumoniaOtitis Media

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Serotype distribution of Streptococcus pneumoniae (Spn) among young children with OM (AOM/OME/CSOM).

    12 months

Study Arms (1)

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

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia

Kuantan, Pahang, 57000, Malaysia

RECRUITING

Universiti Putra Malaysia

Serdang, Seri Kembangan, 43400, Malaysia

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22404948BACKGROUND

  • 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.

    PMID: 22558393BACKGROUND

  • 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.

    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.

    PMID: 9279632BACKGROUND

  • 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.

    PMID: 27888477BACKGROUND

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.

MeSH Terms

Conditions

PneumoniaOtitis Media

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesOtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Lokman Hakim Sulaiman, PhD

    IMU University, Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Alia Johari, PhD

CONTACT

+60 12 234 5651NurAliaJohari@imu.edu.my

Nurul Hanis Ramzi, PhD

CONTACT

+60 17 339 6532nurulhanis@imu.edu.my

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Vice Chancellor, Research

Study Record Dates

First Submitted

June 19, 2022

First Posted

June 23, 2022

Study Start

April 5, 2023

Primary Completion

April 5, 2024

Study Completion

September 30, 2025

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(2)