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Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens

NCT04946084 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-07-29

No results posted yet for this study

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).

Conditions

  • Acute Otitis Media

Interventions

PROCEDURE

Tympanocentesis

When acute otitis media is diagnosed, local anesthetic applied, small hole placed in eardrum, middle ear fluid extracted.

OTHER

Nasal Phalangeal Swab and Wash

Nasal phalangeal swab used to retrieve sample. Nasal wash used to retrieve sample.

OTHER

Blood Draw

Venipuncture

Sponsors & Collaborators

  • Rochester General Hospital

    lead OTHER

Principal Investigators

  • Michael Pichichero, MD · Rochester General Hospital Research Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04946084 on ClinicalTrials.gov