Last reviewed · How we verify
NCT06876259: IMAGE
Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds
NA trial testing Standard Clinical Ear Exam in Acute Otitis Media (AOM) in 300 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Timothy Shope |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 300 |
| Start date | 4 December 2025 |
| Primary completion | 30 December 2026 |
| Estimated completion | 1 July 2027 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Standard Clinical Ear Exam
- AI app ear exam and diagnosis
Conditions studied
- Acute Otitis Media (AOM) — all drugs for Acute Otitis Media (AOM) →
- Upper Respiratory Infection — all drugs for Upper Respiratory Infection →
Sponsor
Timothy Shope
Who can join
Adults 6 Months to 24 Months, any sex, with Acute Otitis Media (AOM) or Upper Respiratory Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Ear infections are common in young children with cold symptoms, but they can be difficult to diagnose due to small ear canals, child movement, and limited viewing time. In this study, investigators will take photos of the eardrums of children 6-24 months of age with upper respiratory symptoms. The photos will be reviewed by imaging software enhanced with artificial intelligence (AI app) to determine whether the AI app changes how ear infections are diagnosed and treated. The AI app has undergone rigorous study and was found to be highly accurate; but how using this technology affects the diagnosis and treatment by clinicians has not been studied. This research may help improve diagnostic accuracy for ear infections and ensure antibiotics are prescribed only for those children who have definite ear infections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06876259
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Otitis Media (AOM)
Currently open trials in the same condition.
- NCT07359287 — Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care · NA · recruiting
- NCT07500532 — Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06876259 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Timothy Shope
- Last refreshed: 7 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06876259.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing