NCT05429541|Unknown
Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.
OM
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OM
Sponsor study identifier
observational
360
1 country
2
Study Start
April 5, 2023
Actual (reported)Primary Completion
April 5, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2022
Actual (reported)June 23, 2022
Actual (reported)April 5, 2023
Actual (reported)April 5, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Serotype distribution of Streptococcus pneumoniae (Spn) among young children with OM (AOM/OME/CSOM).
12 months
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
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.
Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia
Kuantan, Pahang, 57000, Malaysia
Universiti Putra Malaysia
Serdang, Seri Kembangan, 43400, Malaysia
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.
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.
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.
Lokman Hakim Sulaiman, PhD
IMU University, Malaysia
First Submitted
June 19, 2022
First Posted
June 23, 2022
Study Start
April 5, 2023
Actual (reported)Primary Completion
April 5, 2024
Estimated (date passed)Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
Contact the study team to confirm eligibility.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 7, 2023
Record last verified: 2023-08
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