Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children (NCT06285812) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
United States700 participantsStarted 2024-01-10
Plain-language 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.
Who can participate
Age range6 Months – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 peri…
What they're measuring
1
Change the clinician rate of antibiotic prescriptions
Timeframe: Baseline to 12 month Follow Up
2
Change the number of antibiotic rounds per patient
Timeframe: Baseline to 12 month Follow Up
3
Change costs associated with management of pediatric patients presenting with ear-related pain