ActiveNCT06285812

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

Sponsor: PhotoniCare, Inc.

Trial Details

ConditionOtitis Media Acute
InterventionOtoSight Middle Ear Scope
StatusActive
Participants700
Est. Completion1 June 2026
Last Updated12 May 2026

Primary Outcome

Change the clinician rate of antibiotic prescriptions; Change the number of antibiotic rounds per patient; Change costs associated with management of pediatric patients presenting with ear-related pain

Eligibility Criteria

Inclusion Criteria

For the Prospective Subjects Inclusion 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 Exclusion Criteria: * 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.

Trial Sites

Countries

United States
View Registry Entry

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