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

Nasopharyngeal Colonization and Acute Otitis Media Clinical Trial

— AOM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02591563
• Other study ID #: CIC 1141 B-09-1
• Status: Active, not recruiting
• Start date: October 2015
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Rochester General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1320
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

Inclusion Criteria:

Healthy Children:

• Male or female age greater than/equal to 6 months or less than/equal to 36 months old.

• Parent/guardian willing to bring to all study visits

Exclusion Criteria:

• Any major illness/condition that in investigator opinion would put subject at risk during study.

• Otorrhea or tympanostomy tubes present in either ear @ time of enrollment.

• Direct descendant of study site personnel.

• Subjects < 6 months old or >36 months old at the time of enrollment

Related Conditions & MeSH terms

• Nasopharyngeal Colonization and Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Other:
• procedures
Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture

Locations

Country	Name	City	State
United States	Rochester General Hospital	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rochester General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distribution of bacteria causing acute otitis media.	In this study, we are exploring the three main bacteria (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis) isolated from middle ear fluid samples (obtained by tympanocentesis) during acute otitis media episode in children ages 6-36 months.	10 years
Secondary	The distribution of potential otopathogens colonizing the nasopharynx.	In this study we are exploring the three main bacteria (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis) isolated from nasopharynx of children during their routine healthy visits at 6-36 months of age during an AOM episode.	10 years