AI Diagnostic Support for Ear Infections

(IMAGE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Timothy R Shope, MD, MPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Timothy Shope

No Placebo Group

Trial Summary

What is the purpose of this trial?

Ear infections are common in young children with cold symptoms, but they can be difficult to diagnose due to small ear canals, child movement, and limited viewing time. In this study, investigators will take photos of the eardrums of children 6-24 months of age with upper respiratory symptoms. The photos will be reviewed by imaging software enhanced with artificial intelligence (AI app) to determine whether the AI app changes how ear infections are diagnosed and treated. The AI app has undergone rigorous study and was found to be highly accurate; but how using this technology affects the diagnosis and treatment by clinicians has not been studied. This research may help improve diagnostic accuracy for ear infections and ensure antibiotics are prescribed only for those children who have definite ear infections.

Research Team

Timothy R Shope, MD, MPH

Principal Investigator

UPMC Children's Hospital

Eligibility Criteria

This trial is for young children aged 6-24 months who are showing symptoms of upper respiratory infections, such as colds or swimmer's ear. The study aims to include those who may have difficulty with traditional ear exams due to small ear canals or restlessness.

Inclusion Criteria

I currently have an upper respiratory infection.

My child is between 6 to 24 months old.

Exclusion Criteria

I do not have an upper respiratory infection.

I am currently on antibiotics.

I have discharge from my ear.

Treatment Details

Interventions

• AI app (Artificial Intelligence)

Trial Overview The trial is testing the effectiveness of an AI app in diagnosing ear infections compared to standard clinical exams. Photos of eardrums taken during visits will be analyzed by the AI to see if it changes diagnosis and treatment decisions.

Participant Groups

Group I: AI App + Standard of care clinical exam Experimental Treatment 2 Interventions

Using a within subject design, each child's ear will be in the experimental and standard care group. Each ear will be examined by the AI app and a clinician (blinded to the AI app diagnosis) to provide a diagnosis and treatment recommendation.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Community Pediatrics Brentwood Pittsburgh, PA

Children's Community Pediatrics Castle Shannon Pittsburgh, PA

Who Is Running the Clinical Trial?

Timothy Shope

Lead Sponsor

Trials

1

Recruited

300+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University