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

Running, not enrolling

Conditions studied: Otitis Media Acute

In brief

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.

Key facts

Study ID

NCT06285812

Run by

PhotoniCare, Inc.

People needed

700

Starts

2024-01-10

Expected to finish

2026-07-01

Last updated by the study team

2026-05-12

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• For the Retrospective Case Match Controls
• Inclusion Criteria:
• Pediatric subjects between 6 months and 17 years of age (< 18 years old).
• Index visit took place 11 - 25 months prior to the Treatment match's Baseline Visit.
• Index visit was for an ear-related chief complaint.
• An otoscopic exam was completed at index visit.
• Subjects have a follow up visits (telehealth included) in the time period between the index visit and firstTreatment subject's enrollment date.

Where it is running

• Children's National Hospital — Washington D.C., District of Columbia, United States
• Abba Medical Group LLC — Miami, Florida, United States
• AdventHealth Children's Research — Orlando, Florida, United States
• Trillim Health — Rochester, New York, United States
• Cyn3rgy Research — Gresham, Oregon, United States
• Carolina ENT — Orangeburg, South Carolina, United States
• HealthStar Physicians — Morristown, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.