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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

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Characterize which bacterial strains in the NP

Secondary study objectives

Characterize which bacterial strains are AOM causing pathogens

Other study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.