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 range
6 Months – 17 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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