Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04946084 |
Other study ID # |
IRB 2031 A |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2021 |
Est. completion date |
December 31, 2026 |
Study information
Verified date |
November 2023 |
Source |
Rochester General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
Description:
The investigator's proposed study design involves 2 cohorts. Cohort 1: Collection of middle
ear fluid(MEF), NP samples and blood at onset of AOM from otitis prone children and those who
have AOM antibiotic treatment failure since these children more frequently harbor antibiotic
resistant strains. Children will then be followed prospectively thereafter, collecting NP
samples at pre-determined time points when the children are healthy (see cohort 2) and MEF,
NP samples and blood if subsequent AOM infections occur. Cohort 2: Healthy children from whom
we will prospectively collect NP samplings and blood at any of 7 pre-determined time points
(age 6, 9, 12, 15, 18, 24, and/or 30-36 months old as they occur within the study time-frame)
to assess commensal carriage of Spn and Hflu. MEF will be obtained from the participants at
any AOM occurring, including the first and any subsequent AOM infection. Concurrently
detailed demographic, vaccination, epidemiologic and risk factor data known to influence AOM
epidemiology will be collected, providing scientific rigor.
Viral respiratory infections will be another focus during this project. The investigators
will characterize dynamic changes in patterns of viral co-infections at onset of AOM
including the common respiratory viruses RSV A, B, influenza A, B, parainfluenzae virus type
3, rhinovirus, enterovirus, human metapneumovirus, human bocavirus, adenovirus B, C and
SARS-CoV-2. The studies will involve viral identification, evaluation of viral/bacterial
(otopathogen) interactions and mucosal and systemic immune responses.
The investigators have identified multiple deficiencies in innate and adaptive immunity among
young children who are AOM prone and introduced the term "prolonged neonatal-like immune
profile (PNIP) because of striking similarities that resemble neonatal immunity. Another
focus of this project will be to expand understanding of the central immune deficiencies of
APM prone children using blood samples.
A a serum correlate of protection has been defined to predict the effectiveness of
pneumococcal conjugate vaccines using blood samples linked to occurrence of NP colonization
and AOM events in recent past work. Blood will be used to continue this work.