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

Last updated: October 30, 2024
Sponsor: PhotoniCare, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Ear Infections

Ear Infections (Pediatric)

Treatment

OtoSight Middle Ear Scope

Clinical Study ID

NCT06285812
000003
  • Ages 6-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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) havesigned an informed consent

Exclusion

Exclusion Criteria:

  • The parent or guardian who attends visits does not speak the same language as theirphysician

  • 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, noseand throat) or any clinically significant illness or condition that, in the opinionof the investigator, would prohibit the subject from participating in the trial

  • Anatomical conditions that would affect their ability to undergo an otoscopy.

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: OtoSight Middle Ear Scope
Phase:
Study Start date:
January 10, 2024
Estimated Completion Date:
December 30, 2025

Study Description

Mixed method, multi-center, pragmatic, cluster-randomized effectiveness-implementation investigation focused on pediatric subjects presenting with ear complaints at the office setting.

For the prospective randomized component, eligible clinicians at a given site will be randomized to one of two groups: the OtoSight intervention group or the usual care control group. There will be three (3) periods of post-intervention assessment: 10 days (optional), 6 months, and 12 months.

Eligible subjects will be automatically enrolled (or invited to enroll) in the clinical trial and will receive information. Because this is a non-interference design, frontline care clinicians randomized to either arm will be asked to: (1) assess the presence or absence of fluid in the middle ear; (2) record a diagnosis; and (3) treat the patient as they would according to the information available to them.

A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems. Randomization of clinicians (and not children) will decrease contamination in the usual practice group (i.e., so clinicians are not asked to flip between intervention and usual care practices).

Connect with a study center

  • Children's National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Abba Medical Group LLC

    Miami, Florida 33175
    United States

    Site Not Available

  • AdventHealth Children's Research

    Orlando, Florida 32802
    United States

    Active - Recruiting

  • Trillim Health

    Rochester, New York 14620
    United States

    Active - Recruiting

  • Cyn3rgy Research

    Gresham, Oregon 97030
    United States

    Active - Recruiting

  • Carolina ENT

    Orangeburg, South Carolina 29118
    United States

    Active - Recruiting

  • HealthStar Physicians

    Morristown, Tennessee 37813
    United States

    Active - Recruiting

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