Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
AOM
1 other identifier
interventional
320
1 country
1
Brief Summary
The investigators seek to conduct a prospective, longitudinal study to identify the dynamic changes in nasopharyngeal (NP) colonization patterns and acute otitis media (AOM) etiology involving antibiotic-resistant Streptococcus pneumoniae (Spn) and Haemophilus influenzae (Hflu).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 24, 2021
CompletedFirst Posted
Study publicly available on registry
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJuly 29, 2025
July 1, 2025
4.9 years
May 24, 2021
July 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Characterize which bacterial strains in the NP
Identify the presence of Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catharralis in the nasopharynx of children using in vitro culture
30 months
Secondary Outcomes (1)
Characterize which bacterial strains are AOM causing pathogens
30 months
Other Outcomes (3)
Characterize dynamic changes in patterns of viral co-infections at onset of AOM
30 months
Determine immune responses after NP carriage and AOM infections by the common bacterial respiratory pathogens.
30 Months
Determine the serum antibody response that correlates with protection against NP colonization and AOM.
30 months
Study Arms (1)
Healthy Children
OTHERSamples taken from nasal swabs, nasal wash, blood draws and in the case of acute otitis media, tympanocentesis
Interventions
When acute otitis media is diagnosed, local anesthetic applied, small hole placed in eardrum, middle ear fluid extracted.
Nasal phalangeal swab used to retrieve sample. Nasal wash used to retrieve sample.
Eligibility Criteria
You may qualify if:
- Male or female subject age 6 to 12 months + 30 days at the time of enrollment when healthy or up to 36 months old + 30 days with an ear infection.
- Subject has received full (3 dose) infant series of PCV.
- Parent/legal guardian must be able and willing to bring subject to all study visits
You may not qualify if:
- Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
- Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rochester General Hospital
Rochester, New York, 14621, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Pichichero, MD
Rochester General Hospital Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Rochester General Hospital Research Institute
Study Record Dates
First Submitted
May 24, 2021
First Posted
June 30, 2021
Study Start
January 1, 2021
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share