Acute Otitis MediaAOMNCT04946084
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
A study testing Tympanocentesis, Nasal Phalangeal Swab and Wash and Blood Draw in people with Acute Otitis Media, run by Rochester General Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Tympanocentesis, Nasal Phalangeal Swab and Wash and Blood Draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester General Hospital
Rochester, New York, 14621
About this study
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).
Read the detailed 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.
- Conditions
- Acute Otitis Media
- Being tested
- Tympanocentesis, Nasal Phalangeal Swab and Wash, Blood Draw
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TympanocentesisProcedure or surgery
Also called Ear Tap
When acute otitis media is diagnosed, local anesthetic applied, small hole placed in eardrum, middle ear fluid extracted.
Nasal Phalangeal Swab and WashOther
Also called Nasal Swab, Nasal Wash
Nasal phalangeal swab used to retrieve sample. Nasal wash used to retrieve sample.
Blood DrawOther
Venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Healthy Children | Other | Samples taken from nasal swabs, nasal wash, blood draws and in the case of acute otitis media, tympanocentesis Receives: Procedure: Tympanocentesis; Other: Nasal Phalangeal Swab and Wash; Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 months
Secondary outcomes (1)
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
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jan 2021
- Primary completionDec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rochester General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Pichichero, Rochester General Hospital
- Investigators
- Michael Pichichero, MD, Principal investigator, Rochester General Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946084
- Sponsor's protocol ID
- IRB 2031 A
- Acronym
- AOM
- Status last verified
- Aug 2026
- First submitted
- 24 May 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No