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Immune Response Monitoring for Ear Infection (AOM Trial)

N/A

Waitlist Available

Led By Michael Pichichero, MD

Research Sponsored by Rochester General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has received full (3 dose) infant series of PCV

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

AOM Trial Summary

This trial will examine the changes in the types of bacteria present in the nose and their effect on ear infections over time.

Who is the study for?

This trial is for healthy kids aged 6-12 months or those up to 36 months with an ear infection, who've had their full infant series of the PCV vaccine. They must be able to attend all study visits. Kids with major illnesses or in other trials within the last 28 days can't join.Check my eligibility

What is being tested?

Researchers are studying how bacteria that cause ear infections change over time in young children's noses and ears. They're doing this by taking samples from the nose and ear, as well as blood tests, especially looking at antibiotic-resistant germs.See study design

What are the potential side effects?

The procedures may include some discomfort like brief pain during swabbing or drawing blood, possible nosebleeds from nasal swabs, and risks associated with tympanocentesis such as temporary hearing loss or eardrum perforation.

AOM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received all 3 doses of the pneumonia vaccine as a baby.

AOM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Characterize which bacterial strains in the NP

Secondary outcome measures

Characterize which bacterial strains are AOM causing pathogens

Other outcome measures

Characterize dynamic changes in patterns of viral co-infections at onset of AOM

Determine immune responses after NP carriage and AOM infections by the common bacterial respiratory pathogens.

Determine the serum antibody response that correlates with protection against NP colonization and AOM.

AOM Trial Design

1Treatment groups

Experimental Treatment

Group I: Healthy ChildrenExperimental Treatment3 Interventions

Samples taken from nasal swabs, nasal wash, blood draws and in the case of acute otitis media, tympanocentesis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tympanocentesis

2010

N/A

~240

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rochester General HospitalLead Sponsor

13 Previous Clinical Trials

1,958 Total Patients Enrolled

Michael Pichichero, MD4.210 ReviewsPrincipal Investigator - Rochester General Hospital Research Institute

Rochester General Hospital

5Patient Review

I found Dr. Pichichero to be an excellent doctor, even though the staff wasn't always the friendliest. I continued taking my son to him because he was worth it. My sons are now 41 and 38 years old, and his name still gets brought up occasionally. He must still be a great doctor.

Media Library

Tympanocentesis Clinical Trial Eligibility Overview. Trial Name: NCT04946084 — N/A

Ear Infection Clinical Trial 2023: Tympanocentesis Highlights & Side Effects. Trial Name: NCT04946084 — N/A

Tympanocentesis 2023 Treatment Timeline for Medical Study. Trial Name: NCT04946084 — N/A

Ear Infection Research Study Groups: Healthy Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are enlisted in this clinical trial?

"Confirmed. According to information on clinicaltrials.gov, this medical research project was first posted in January 2021 and has since been updated several times; it is currently seeking 320 patients from a single facility."

Answered by AI

Is this scientific experiment currently enrolling participants?

"Clinicaltrials.gov reports that this research endeavour is actively recruiting, having been first posted on 1/1/2021 and last updated on 11/1/2022."

Answered by AI

Who is eligible for participation in this research project?

"This medical investigation is looking to enrol 320 infants, aged 6 months up to 36 months and 30 days old, suffering from otitis media. Essential requirements for inclusion are the completion of a three-dose infant series of PCV vaccination; parents or legal guardians must be capable and willing to transport their child to all scheduled visits; male or female participants must fall within the specified age range when healthy or with an ear infection."

Answered by AI

Does this trial have an age cap, and if so, what is it?

"This trial is exclusively available to patients between the ages of 6 months and 36 months. For individuals under 18, there are 17 separate clinical trials; conversely, 3 more studies exist for subjects aged over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Michael Pichichero 2021. "Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04946084.