Otitis Treatment with OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

Description

A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.

Conditions

Otitis Media Acute

Study Overview

Study Details

Study overview

A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.

OTO-MATIC: Otitis Treatment with OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

Otitis Treatment with OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

Condition
Otitis Media Acute
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Miami

Abba Medical Group LLC, Miami, Florida, United States, 33175

Orlando

AdventHealth Children's Research, Orlando, Florida, United States, 32802

Rochester

Trillim Health, Rochester, New York, United States, 14620

Gresham

Cyn3rgy Research, Gresham, Oregon, United States, 97030

Orangeburg

Carolina ENT, Orangeburg, South Carolina, United States, 29118

Morristown

HealthStar Physicians, Morristown, Tennessee, United States, 37813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pediatric subjects between 6 months and 17 years of age
  • * Pediatric subjects presenting for an office visit with ear-related pain (otalgia)/otic complaints/earache indicative of potential Otitis Media with Effusion (OME) or Acute Otitis Media (AOM)
  • * Pediatric subjects where otoscopy would traditionally be indicated
  • * Pediatric subjects whose parents or legally authorized representative (LAR) have signed an informed consent
  • * The parent or guardian who attends visits does not speak the same language as their physician
  • * Pediatric subjects enrolled in another clinical trial
  • * Pediatric subjects with:
  • * Signs of severe chronic illness (e.g., immunodeficiency, congenital heart disease, encephalopathy, pulmonary disease other than asthma, and disorder of the ear, nose and throat) or any clinically significant illness or condition that, in the opinion of the investigator, would prohibit the subject from participating in the trial
  • * Anatomical conditions that would affect their ability to undergo an otoscopy.

Ages Eligible for Study

6 Months to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

PhotoniCare, Inc.,

Study Record Dates

2025-12-30