Otitis Media AcuteOTO-MATICNCT06285812
Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
An observational study of Otitis Media Acute, run by PhotoniCare, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media Acute
- What is being tested?
- OtoSight Middle Ear Scope
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Jan 2024to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Any pediatric patient between 6 months and 17 years of age scheduled for an office visit with ear-related complaints, deemed suitable for otoscopy assessment.
Who may be able to join
- 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
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cyn3rgy Research
Gresham, Oregon, 97030
Abba Medical Group LLC
Miami, Florida, 33175
HealthStar Physicians
Morristown, Tennessee, 37813
Carolina ENT
Orangeburg, South Carolina, 29118
AdventHealth Children's Research
Orlando, Florida, 32802
Trillim Health
Rochester, New York, 14620
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: OTO-MATIC: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
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.
Read the detailed 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).
- Conditions
- Otitis Media Acute
- Being tested
- OtoSight Middle Ear Scope
- Keywords
- Otitis Media with Effusion, Ear Infection, Optical Coherence Tomography, Otitis Media, Machine Learning
- Medical subject headings
- Otitis Media, Otitis Media with Effusion, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtoSight Middle Ear ScopeDevice
Subjects will be evaluated with the OtoSight Middle Ear Scope
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care #1 | Prospective Randomized Control Trial (RCT) | |
| OtoSight #1 | Prospective Randomized Control Trial (RCT) Receives: Device: OtoSight Middle Ear Scope | |
| OtoSight #2 | Case and provider match Receives: Device: OtoSight Middle Ear Scope | |
| Standard of Care #2 | Retrospective case and provider matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the clinician rate of antibiotic prescriptions
Antibiotic stewardship
Measured: Baseline to 12 month Follow Up
Change the number of antibiotic rounds per patient
Antibiotic stewardship
Measured: Baseline to 12 month Follow Up
Change costs associated with management of pediatric patients presenting with ear-related pain
Change in overall costs
Measured: Baseline to 21 month Follow Up
Secondary outcomes (9)
Change in unnecessary antibiotic prescriptions
Change in unnecessary antibiotic prescriptions based on reported diagnosis and treatment recommendations of providers
Measured: Baseline to 12 month Follow Up
Change in prescription adherence
Change in prescription adherence
Measured: Baseline to 12 month Follow Up
Change in antibiotic prescription rate when fluid not present
Change in antibiotic prescriptions rate when fluid is not present based on reported treatment recommendations of providers
Measured: Baseline to 12 month Follow Up
Improve patient outcomes
Change in progression to recurrent AOM (rAOM) based on tracking provider diagnoses
Measured: Baseline to 12 month Follow Up
Change medical resource utilization
Change in follow-up visit frequency, ENT (Ear, Nose, and Throat) referral frequency
Measured: Baseline to 30 days Follow Up
Change unnecessary medical intervention
Change in amount of unnecessary medical intervention (e.g., tympanostomy tube surgeries) based on tracking provider treatment recommendations and diagnoses
Measured: Baseline to 12 month Follow Up
Impact clinician confidence
Change in clinician confidence scores reported on Provider CRF
Measured: Baseline to 12 month Follow Up
Impact caregiver satisfaction
Change in clinician satisfaction scores reported on Provider CRF
Measured: Baseline to 12 month Follow Up
Change in Health-related Quality of Life (HQoL)
Change in HQoL scores reported on the OMO-22 and OM-6
Measured: Baseline to 12 month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start10 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PhotoniCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TTi Health Research & Economics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285812
- Sponsor's protocol ID
- 000003
- Acronym
- OTO-MATIC
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OTO-MATIC: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
- ClinicalTrials.gov ID
- NCT06285812
- Acronym / sponsor ID
- OTO-MATIC / 000003
- Conditions
- Otitis Media Acute
- Keywords
- Otitis Media with Effusion, Ear Infection, Optical Coherence Tomography, Otitis Media, Machine Learning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- PhotoniCare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- TTi Health Research & Economics
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care #1 | – | –Prospective Randomized Control Trial (RCT) |
| OtoSight #1 | – | Device: OtoSight Middle Ear ScopeProspective Randomized Control Trial (RCT) |
| OtoSight #2 | – | Device: OtoSight Middle Ear ScopeCase and provider match |
| Standard of Care #2 | – | –Retrospective case and provider matched controls |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Any pediatric patient between 6 months and 17 years of age scheduled for an office visit with ear-related complaints, deemed suitable for otoscopy assessment.
Key inclusion criteria (9 listed)
- 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
- Pediatric subjects between 6 months and 17 years of age (< 18 years old).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtoSight Middle Ear ScopeSubjects will be evaluated with the OtoSight Middle Ear Scope | Device | OtoSight #1, OtoSight #2 |
Primary outcome
Change the clinician rate of antibiotic prescriptions
Time frame: Baseline to 12 month Follow Up
Antibiotic stewardship
Change the number of antibiotic rounds per patient
Time frame: Baseline to 12 month Follow Up
Antibiotic stewardship
Change costs associated with management of pediatric patients presenting with ear-related pain
Time frame: Baseline to 21 month Follow Up
Change in overall costs
9 secondary outcomes
Change in unnecessary antibiotic prescriptions
Time frame: Baseline to 12 month Follow Up
Change in prescription adherence
Time frame: Baseline to 12 month Follow Up
Change in antibiotic prescription rate when fluid not present
Time frame: Baseline to 12 month Follow Up
Improve patient outcomes
Time frame: Baseline to 12 month Follow Up
Change medical resource utilization
Time frame: Baseline to 30 days Follow Up
Change unnecessary medical intervention
Time frame: Baseline to 12 month Follow Up
Impact clinician confidence
Time frame: Baseline to 12 month Follow Up
Impact caregiver satisfaction
Time frame: Baseline to 12 month Follow Up
Change in Health-related Quality of Life (HQoL)
Time frame: Baseline to 12 month Follow Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
Related trials for Otitis Media Acute
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Active, not recruitingObservational study
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Nasopharyngeal Colonization and Acute Otitis Media
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media Acute, run by PhotoniCare, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the clinician rate of antibiotic prescriptions (time frame: Baseline to 12 month Follow Up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.