50 completed, 7 unknown, 6 terminated, 3 recruiting. 22 Not applicable, 18 Phase 3, 11 Phase 2, 9 Phase 4, 1 Phase 1.
Follow Acute Otitis Media: new trials by email Literature Review of Acute Otitis Media trials Research Report on Acute Otitis Media
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children Amoxicillin, Amoxicillin + Clavulanate, Placebo - Acute Otitis Media, AOM - Acute Otitis Media | Phase 4 | Not yet recruiting | Kuopio University Hospital | 219 | 2026-11-01 | 2026-10-16 |
| Parent-led Assessment and Recognition of AOM Using Digital Ear Imaging Assigning of a digital otoscope to the families in the intervention group - Acute Otitis Media, Otitis Media | Not applicable | Recruiting | Turku University Hospital | 40 | 2026-09-01 | 2026-09-08 |
| Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study) Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension, Saccharomyces boulardii CNCM I-745 - Antibiotic Associated Diarrhea, Acute Otitis Media | Phase 4 | Completed | Eskisehir Osmangazi University | 100 | 2025-08-01 | 2026-09-11 |
| Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children Amoxicillin, Clavulanic Acid - Acute Otitis Media | Not applicable | Not yet recruiting | University of Health Sciences Lahore | 162 | 2025-05-01 | 2025-03-30 |
| Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections Changes to the electronic health record (EHR), Individualized audit and feedback reporting for clinicians, Clinician education sessions - Acute Otitis Media, Ear Infection | Not applicable | Recruiting | Intermountain Health Care, Inc. | 1566 | 2025-02-03 | 2025-09-03 |
| RELAX: Reducing Length of Antibiotics for Children With Ear Infections High Intensity Intervention, Low Intensity Intervention - Acute Otitis Media, Pediatric Infectious Disease | Not applicable | Active not recruiting | Intermountain Health Care, Inc. | 500 | 2024-04-01 | 2025-08-17 |
| Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry Iontophoresis and tube placement - Otitis Media With Effusion, Acute Otitis Media | Recruiting | Smith & Nephew, Inc. | 200 | 2023-06-15 | 2024-07-23 | |
| Supporting Parents to Choose Wisely Blogshots 1-3, Blogshots 4-6 - Common Cold, Pharyngitis | Not applicable | Completed | University of Alberta | 174 | 2023-06-05 | 2025-05-22 |
| Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions Quasi experimental intervention - Community-acquired Pneumonia, Acute Otitis Media | Not applicable | Completed | Children's Hospital of Philadelphia | 26139 | 2022-10-18 | 2025-11-14 |
| Analgesic Ear Drops for Children With Acute Otitis Media lidocaine hydrochloride 5mg/g - Acute Otitis Media, Pain | Phase 3 | Terminated | UMC Utrecht | 29 | 2021-10-06 | 2026-07-16 |
| Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens Tympanocentesis, Nasal Phalangeal Swab and Wash, Blood Draw - Acute Otitis Media | Not applicable | Active not recruiting | Rochester General Hospital | 320 | 2021-01-01 | 2026-10-21 |
| Evaluation of Cellphone Based Otoscopy in Pediatric Patients Cellscope - Ear Infection, Pediatric Disease | Not applicable | Completed | Johns Hopkins University | 197 | 2019-09-01 | 2021-08-26 |
| An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years Detection of Streptococcus pneumoniae strains - Pneumonia, Pneumococcal, Invasive Pneumococcal Disease | Not applicable | Completed | The Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC) | 500 | 2019-06-01 | 2021-02-11 |
| A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months OP0201, Placebo, Amoxicillin-clavulanate - Acute Otitis Media | Phase 2 | Completed | Novus Therapeutics, Inc | 103 | 2019-02-21 | 2020-08-18 |
| Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media Drug: OP0201 20mg, Drug: Placebo 0mg - Acute Otitis Media | Phase 1 | Completed | Novus Therapeutics, Inc | 24 | 2019-01-07 | 2019-12-05 |
| Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR) Lactobacillus salivarius PS7 during 6 months, Lactobacillus salivarius PS7 during 3 months, placebo - Acute Otitis Media | Not applicable | Completed | ProbiSearch SL | 222 | 2018-10-02 | 2020-10-22 |
| Efficacy of the EarPopper Device in Children With Recurrent Otitis Media EarPopper - Recurrent Acute Otitis Media, Acute Otitis Media | Not applicable | Withdrawn | Northwell Health | 2018-07-24 | 2020-12-23 | |
| Bio-Kult Infantis® in AAD Prevention in Infants Biokult, Placebo - Acute Otitis Media | Not applicable | Unknown | Probiotics International Ltd. | 276 | 2018-04-18 | 2018-09-12 |
| Taste Changes in Acute Otitis Media Electrogustometery - Acute Otitis Media | Unknown | Tel-Aviv Sourasky Medical Center | 40 | 2018-03-01 | 2017-10-19 | |
| Xylitol for the Prevention of Acute Otitis Media Episodes in Children Xylitol syrup, Placebo - Acute Otitis Media, URTI | Not applicable | Unknown | Unity Health Toronto | 472 | 2017-03-31 | 2019-09-06 |
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Otitis Media (72) · Otitis (17) · Otitis Media with Effusion (5) · Pain (5) · Pharyngitis (3) · Bronchiolitis (2) · Earache (2) · Pneumococcal Infections (2) · Pneumonia (2) · Respiratory Tract Infections (2) · Tympanic Membrane Perforation (2) · Atrial Fibrillation (1) · Bronchitis (1) · Common Cold (1) · Community-Acquired Pneumonia (1)
Ear Diseases (72) · Otorhinolaryngologic Diseases (72) · Otitis (55) · Infections (12) · Pathological Conditions, Signs and Symptoms (10) · Respiratory Tract Diseases (9) · Signs and Symptoms (9) · Neurologic Manifestations (7) · Respiratory Tract Infections (7) · Lung Diseases (6) · Lung Diseases, Obstructive (4) · Bacterial Infections (3) · Bacterial Infections and Mycoses (3) · Bronchial Diseases (3) · Gram-Positive Bacterial Infections (3)
Amoxicillin-Potassium Clavulanate Combination (9) · Amoxicillin (5) · Benzocaine (3) · Cefdinir (3) · Ciprofloxacin (3) · Azithromycin (2) · Data Collection (2) · Dexamethasone (2) · 23-valent pneumococcal capsular polysaccharide vaccine (1) · Antipyrine (1) · Blood Specimen Collection (1) · Boostrix (1) · Clavulanic Acid (1) · Educational Status (1) · Iontophoresis (1)
Alcon Research (6) · GlaxoSmithKline (4) · Abbott (3) · Pfizer (3) · Alejandro Hoberman (2) · Arbor Pharmaceuticals, Inc. (2) · Children's Hospital of Philadelphia (2) · Integra LifeSciences Corporation (2) · Intermountain Health Care, Inc. (2) · Novus Therapeutics, Inc (2) · Otonomy, Inc. (2) · Salvat (2) · University of Alberta (2) · University of Washington (2) · Asociacion Colaboracion Cochrane Iberoamericana (1)
United States (36) · Canada (5) · Finland (4) · Israel (4) · Spain (4) · Costa Rica (3) · Australia (2) · Chile (2) · Dominican Republic (2) · Guatemala (2) · Panama (2) · Russia (2) · Argentina (1) · Colombia (1) · Estonia (1)
Alejandro Hoberman, MD (3) · Amanda J Leach, PhD (2) · Carl LeBel, PhD (2) · Edward K Mulholland, DM (2) · Jonathan R Carapetis, PhD (2) · Laurence J Downey, MD (2) · Peter S Morris, PhD (2) · Ross M Andrews, PhD (2) · Aino Ruohola, MD, PhD (1) · Amy Agua, MD (1) · Andrea Shane, MD, MPH, MSc (1) · Andrew C Dixon, MD (1)
PMID 42572144, PMID 28006041, PMID 36211411, PMID 37171965, PMID 20368317, PMID 21098526, PMID 21226576, PMID 21226577, PMID 24394686, PMID 24911895, PMID 25085073, PMID 25923426, PMID 26183005, PMID 26529076, PMID 26651157, PMID 28002709, PMID 28340091, PMID 28438923, PMID 29544905, PMID 30082349, PMID 30572868, PMID 30603376, PMID 32574101, PMID 32966144, PMID 33979487, PMID 34851411, PMID 36168454, PMID 36470464, PMID 36813504, PMID 37784098, PMID 37855227, PMID 37890960, PMID 38267837, PMID 39656188, PMID 39781291, PMID 40753428, PMID 41241139, PMID 42173560
2014 (1), 2025 (1), RC1DC010668-01 (1), U01AI066007 (1), U01DC013995 (1)