An interventional study of Tele-Otoscope Enabled Primary Care and eBook-supported primary care in Acute Respiratory Tract Infection, Ear Infection and Throat Infection, sponsored by University of Pittsburgh. Not yet recruiting at 2 sites in United States. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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Among 45 studies in Otitis with a site in United States — 5 open to participants now, 11 under way, none of them phase 3. Otitis · United States.
Among the 45 studies in Otitis with a site in United States, this one is the 6th largest by planned enrollment of the 31 interventional ones that give a count, is one of 3 that started in 2026, is one of 17 with no phase, reaches primary completion later than 9 of the 10 other live ones, and was the 45th registered.
80 studies on the registry are indexed under Otitis; 10 are open to participants now.
Browse Otitis studies →5 of the 45 studies in Otitis with a site in United States are open now. Recruiting first, the newest first:
Nader Shaikh · Sites in United States
Ages 6 mo–36 mo
Stanford University · Sites in United States
Ages 1–17
Intermountain Health Care, Inc. · Sites in United States
Ages 6 mo–17 yrs
BelleTorus Corporation · Sites in United States
Ages 1–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Otitis studies recruiting now, 2 set no upper age limit and 6 stop at 75 or younger; 7 take children under 18; none take healthy volunteers.
This study: 6 Months to 24 Months · all sexes · no healthy volunteers.
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45 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 450 is above the median of 183 across 54 interventional studies indexed under Otitis.
Median enrollment 178 across the 31 interventional studies, 152 across the 14 observational. Of the 34 that completed or were terminated, 16 (47%) have results posted.
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16 of 45 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 7 studies filed under Otitis — fewer than ten, so there is no comparison to draw.
4 of the studies in Otitis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608993Intermountain Health Care, Inc.RELAX: Reducing Length of Antibiotics for Children With Ear Infections | 2027-04 |
| NCT06944795Stanford UniversitySWIR Otoscopy Study | 2027-04-30 |
| NCT06429709Baylor College of MedicineUtility of Advanced Ultrasound Otoscope In The Diagnosis of AOM | 2027-05-31 |
| NCT06034080Intermountain Health Care, Inc.Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections | 2027-06-01 |
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Among the 45 studies in Otitis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Young children often receive antibiotics for pediatric acute respiratory tract infections (ARTIs) - common childhood diagnoses like ear infections, strep throat, sinusitis, and colds - but many of these antibiotics are prescribed unnecessarily for viral infections, where antibiotics will not help. Helping families and pediatricians to evaluate children with ARTIs through primary care telemedicine visits using at-home tele-otoscopes vs. at-home eBooks could help reduce unnecessary antibiotic exposure in children. In this clinical trial, the investigators will assess the impact of at-home tele-otoscope vs. eBook enabled primary care telemedicine on antibiotic use, healthcare utilization, and healthcare costs for young children.
This is an interventional study. In this two-arm randomized controlled trial, randomization will occur stratified by child age at enrollment (6-14 months, 15-23 months) and study site. The trial will be conducted in academic and community pediatric practices. This study includes two prespecified, parallel analyses in the following aims:
Aim 1: Assess the impact of tele-otoscope vs. eBook enabled primary care practice (PCP) telemedicine for pediatric ARTIs on antibiotic prescribing and healthcare utilization among young children who have at least one prior episode of AOM.
Aim 2: Assess the economic consequences from a payer perspective of providing at-home tele-otoscopes vs. eBooks to young children who have at least a prior episode of AOM.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children randomized to the experimental arm will receive a tele- otoscope and ear irrigation device (to assist cerumen removal if needed); parents will be trained on the use of these devices. Parents will be asked to download the tele-otoscope app which will allow them to view and record from the tele-otoscope camera. These devices (tele-otoscope and ear irrigation device) are commercially available and their functionality is not being tested in this study.
Other: Tele-Otoscope Enabled Primary Care
Children randomized to the control arm will receive an eBook on baby and toddler care from the American Academy of Pediatrics. As in prior studies of tele-services, the investigators will provide the eBook as a "digital placebo." Thus, participants in both arms receive an electronic resource, but the eBook has limited content specific to ARTI care, such that it is not expected to significantly influence study outcomes.
Other: eBook-supported primary care
Children randomized to the experimental arm will receive a tele- otoscope and ear irrigation device (to assist cerumen removal if needed); parents will be trained on the use of these devices. Parents will be asked to download the tele-otoscope app which will allow them to view and record from the tele-otoscope camera. These devices (tele-otoscope and ear irrigation device) are commercially available and their functionality is not being tested in this study, which focuses instead on testing the impact of their availability when integrated into primary care telemedicine.
Children randomized to the control arm will receive an eBook on baby and toddler care from the American Academy of Pediatrics. As in prior studies of tele-services, the investigators will provide the eBook as a "digital placebo." Thus, participants in both arms receive an electronic resource, but the eBook has limited content specific to ARTI care, such that it is not expected to significantly influence study outcomes.
Number of ARTI antibiotics
Number of antibiotic courses prescribed for acute respiratory tract infections (ARTIs) per participant from enrollment through 12 months after enrollment. An antibiotic course is defined according to the study protocol. This is the primary outcome for the first pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Total annual healthcare costs from the payer perspective
Total healthcare costs incurred per participant from the payer perspective from enrollment through 12 months after enrollment, reported in U.S. dollars. This is the primary outcome for the second pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Number of ARTI antibiotic days prescribed
Total number of days of antibiotic therapy prescribed for ARTI per participant from enrollment through 12 months after enrollment. This is a secondary outcome for the first pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Number of ARTI broad-spectrum antibiotic courses
Number of broad-spectrum antibiotic courses prescribed for ARTI per participant from enrollment through 12 months after enrollment. Broad-spectrum antibiotics are defined according to the study protocol. This is a secondary outcome for the first pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Number of total antibiotic courses (any diagnosis)
Number of antibiotic courses prescribed for any diagnosis per participant from enrollment through 12 months after enrollment. This is a secondary outcome for the first pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Number of ARTI visits overall and by site (ED, urgent care, primary care)
Number of visits for acute respiratory tract infections (ARTIs) per participant from enrollment through 12 months after enrollment, summarized overall and by visit setting (emergency department, urgent care, and primary care). This is a secondary outcome for the first pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Percentage of ARTI visits resulting in antibiotic prescription
Percentage of ARTI visits resulting in an antibiotic prescription from enrollment through 12 months after enrollment, summarized overall and by visit setting (emergency department, urgent care, and primary care). This is a secondary outcome for the first pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Total annual family out of pocket costs
Total family out-of-pocket healthcare costs per participant from enrollment through 12 months after enrollment, reported in U.S. dollars. This is a secondary outcome for the second pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Total annual costs from the primary care practice perspective
Total healthcare costs from the primary care practice perspective per participant from enrollment through 12 months after enrollment, reported in U.S. dollars. This is a secondary outcome for the second pre-specified analysis.
Time frame: From enrollment through 12 months after enrollment
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices).
Time frame: 12 months after final publication until 36 months after publication
Access criteria: Researchers will be able to access de-identified IPD by contacting the principal investigator and securing data use agreements.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2030, 41 months later.
Of 19 interventional studies with no phase under Otitis, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 74. This study's planned 41 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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