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

Running, not enrolling · Not applicable

Conditions studied: Acute Otitis Media

In brief

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).

Key facts

Study ID

NCT04946084

Run by

Rochester General Hospital

People needed

320

Starts

2021-01-01

Expected to finish

2026-12-31

Last updated by the study team

2025-07-29

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Rochester General Hospital — Rochester, New York, United States

Full record on ClinicalTrials.gov

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