NCT02591563

Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

A Study Evaluating Pathogens and Immunity to Acute Otitis Media and Nasopharyngeal Colonization in Healthy Children.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,320 (actual)
• Sponsor: Rochester General Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

Detailed description

A prospective evaluation of bacterial pathogens Streptococcus. pneumoniae, Haemophilus influenzae, Moraxella. catarrhalis and Staphylococcus aureus and their antibiotic susceptibility when colonizing the nasopharynx and/or causing acute otitis media in the years 2015-2025. The goal will be to recruit children into a prospective group beginning at 6 months of age and followed to 36 months of age in suburban Rochester, New York. Nasopharyngeal and nasal wash samples will be obtained at each well child visit and at acute otitis media (AOM) episodes. Middle ear fluid will be obtained from every child with an acute otitis media episode who undergoes a tympanocentesis procedure. All of the nasopharyngeal and middle ear fluid samples collected will be tested by standard microbiologic techniques to identify the presence of 4 potential otopathogens (S. pneumoniae, H. influenzae, M. catarrhalis and S. aureus). All S. pneumoniae will undergo serotyping and antibiotic susceptibility testing. All samples that are culture negative will be evaluated with a multi-locus PCR test to examine for presence of potential otopathogens.

Conditions

• Nasopharyngeal Colonization and Acute Otitis Media

Interventions

Type	Name	Description
OTHER	procedures	Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture

Timeline

• Start date: 2015-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2015-10-29
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States