An interventional study of Tympanocentesis and Nasal Phalangeal Swab and Wash in Acute Otitis Media, sponsored by Rochester General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Rochester General Hospital · Not applicable, Interventional, and Other
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).
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.
284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.
This study's planned enrollment of 320 is above the median of 126 across 194 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Rochester General Hospital is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Samples taken from nasal swabs, nasal wash, blood draws and in the case of acute otitis media, tympanocentesis
Procedure: Tympanocentesis · Other: Nasal Phalangeal Swab and Wash · Other: Blood Draw
When acute otitis media is diagnosed, local anesthetic applied, small hole placed in eardrum, middle ear fluid extracted.
Also known as: Ear Tap
Nasal phalangeal swab used to retrieve sample. Nasal wash used to retrieve sample.
Also known as: Nasal Swab, Nasal Wash
Venipuncture
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
Time frame: 30 months
Characterize which bacterial strains are AOM causing pathogens
Identify the presence of Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catharralis in the nasopharynx of children using in vitro culture
Time frame: 30 months
Characterize dynamic changes in patterns of viral co-infections at onset of AOM
Identify respiratory viruses present in the nasopharynx at onset of acute otitis media in young children using polymerase chain reaction methods.
Time frame: 30 months
Determine immune responses after NP carriage and AOM infections by the common bacterial respiratory pathogens.
Measure serum and nasopharyngeal antibody levels to common bacterial and viral respiratory pathogens with ELISA and immune cellular responses (B cells, T cells, Antigen Presenting cells using flow cytometry and ELISPOT
Time frame: 30 Months
Determine the serum antibody response that correlates with protection against NP colonization and AOM.
Establish a correlate of protection for pneumococcal serotypes that colonize the nasopharynx and cause acute otitis media in young children using ELISA
Time frame: 30 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rochester General Hospital