Rochester, New York 14621


Purpose:

The purpose of this study is to assess the effectiveness of Prevnar 13 against pneumococcal acute otitis media.


Study summary:

A prospective evaluation of the serotypes and antibiotic susceptibility of pneumococci colonizing the nasopharynx and causing acute otitis media in the years 2015-2019. 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 oropharyngeal swabs will be obtained at each well child visit and at acute otitis media episodes. Middle ear fluid will be obtained from every child with every acute otitis media episode. Children who are otitis prone will be invited to join the prospective group thereafter (our experience to date suggests about 60% will continue in the prospective follow up). All of the nasopharyngeal and middle ear fluid samples collected will be tested by standard microbiologic techniques to identify the presence of 5 potential otopathogens (S. pneumoniae, nontypeable Haemophilus influenzae, M. catarrhalis, and Alloiococcus otitidis. All S. pneumoniae will undergo antibiotic susceptibility testing. All samples that are culture negative will be evaluated with a multi-locus PCR test to examine for presence of the 5 potential otopathogens.


Criteria:

Inclusion Criteria: - Male or female aged < 407 days or less than/equal to 36 months old and meets recurrent acute otitis media criteria - Child has received full ( 3 dose ) infant series of Prevnar 13 - 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. - Participation in another investigational/interventional trial within 28 days prior or during study. ( Observational study is permitted ) - Direct descendant of study site personnel.


NCT ID:

NCT02591563


Primary Contact:

Principal Investigator
Michael E Pichichero, MD
Rochester General Hospital

Michael E Pichichero, MD
Phone: 585-922-5959
Email: michael.pichichero@rochesterregional.org


Backup Contact:

N/A


Location Contact:

Rochester, New York 14621
United States

Shelley L Secor-Socha, MS, CCRA
Phone: 585-233-2127
Email: shelley.secor-socha@rochesterregional.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.