Clinical trials: AOM - Acute Otitis Media
Acute Otitis Media
Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops.
- Trial name
- NCT02074007
- Testing
- AR01
- Where
- 21 sites in United States
- Volunteers
- 178 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Acute Otitis Media
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence…
- Trial name
- NCT01044030
- Testing
- Xylitol syrup
- Where
- 2 sites in United States
- Volunteers
- 326 people
- Sponsor
- Boston Children's Hospital
Otitis Media Acute
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.
- Trial name
- OTO-MATIC (NCT06285812)
- Testing
- OtoSight Middle Ear Scope
- Where
- 7 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- PhotoniCare, Inc.
AOM - Acute Otitis Media
Delayed Antibiotic Therapy in General Practice
Introduction In 2019, France was the 4th highest consumer of antibiotics in Europe. Among the interventions proposed to reduce antibiotic prescribing, delayed prescribing deserves particular attention.
- Trial name
- ADOMA (NCT05361239)
- Where
- France
- Volunteers
- 865 people
- Sponsor
- CNGE Conseil
Otitis Media With Effusion, Acute Otitis Media
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure…
- Conditions
- Otitis Media With Effusion, Acute Otitis Media, Otitis Media
- Trial name
- NCT05915078
- Testing
- Iontophoresis and tube placement
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Smith & Nephew, Inc.
Otitis Media
Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life.
- Trial name
- COMIT1 (NCT00539149)
- Testing
- Amoxycillin
- Where
- Australia
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
Acute Otitis Media
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at…
- Trial name
- NCT02630992
- Testing
- Amoxicillin-Clavulanate potassium
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Nader Shaikh
Acute Otitis Media, Pneumonia
Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the…
- Trial name
- NCT02567747
- Testing
- Data collection
- Where
- Colombia
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Otitis Media
Video Discharge Instructions for Acute Otitis Media
Thorough, understandable discharge instructions empower caregivers, allowing them to provide optimum care of their children during illness. Unfortunately discharge instructions are often incomplete and difficult to understand.
- Trial name
- NCT02788422
- Testing
- Video discharge instructions, Standard of Care
- Where
- Canada
- Volunteers
- 219 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Streptococcus Pneumoniae, Nasopharyngeal Carriage
Carriage of Streptococcus Pneumoniae in Infants With Acute Otitis Media and in Infants Attending Day-care Centers
Rationale In Belgium, a unique situation exists for two reasons: on the one hand, the pneumococcal conjugate vaccine (PCV) program, which started in 2007, has quickly reached high coverage in infants: 3-dose coverage rose from 89…
- Trial name
- NCT02888457
- Testing
- Nasopharyngeal sampling with a swab
- Where
- Belgium
- Volunteers
- 2,817 people, healthy volunteers welcome
- Sponsor
- Pierre Van Damme
Otitis Media
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute…
- Trial name
- NCT00051753
- Testing
- levofloxacin; amoxicillin/clavulanate
- Volunteers
- 1,643 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Otitis Media Acute, Otitis Media Effusion
Gamified Training and AI Support for Improving Ear Infection Diagnosis in Primary Care
Acute otitis media (AOM), or middle ear infection, is one of the most common childhood infections and a leading cause of antibiotic prescribing in primary care.
- Trial name
- NCT07246551
- Testing
- AOM Dx Trainer (gamified educational program), No Intervention - Standard Care
- Volunteers
- 200 people
- Sponsor
- Vastra Gotaland Region
Recurrent Acute Otitis Media, Acute Otitis Media
Efficacy of the EarPopper Device in Children With Recurrent Otitis Media
This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper device (EP) in the reduction of episodes of acute otitis media (AOM) in children with recurrent otitis media.
- Trial name
- NCT03534219
- Testing
- EarPopper
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Northwell Health
Barotrauma;Ear, OME - Otitis Media With Effusion
Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting.
- Conditions
- Barotrauma;Ear, OME - Otitis Media With Effusion, AOM - Acute Otitis Media, Eustachian Tube Dysfunction
- Trial name
- ADEPT (NCT03197558)
- Testing
- Tymbion Iontophoresis and Tube Delivery System (TDS)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tusker Medical
Acute Otitis Media
Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
- Trial name
- NCT00579189
- Testing
- Moxidex otic solution, Moxifloxacin otic solution, Tympanostomy tubes
- Volunteers
- 776 people
- Sponsor
- Alcon Research
Acute Otitis Media
Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora
The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial…
- Trial name
- NCT01027494
- Testing
- Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
- Where
- United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Alcon Research
Acute Otitis Media, Acute Otitis Externa
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide.
- Trial name
- NCT02918773
- Testing
- Smartphone otoscope, Conventional otoscope
- Where
- 2 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Emory University
Acute Otitis Media
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management will meaningfully improve children's acute otitis media (AOM) experience over the succeeding 2 years.
- Trial name
- NCT02567825
- Testing
- Tympanostomy tube placement, Amoxicillin-Clavulanate and/or Ceftriaxone, Ofloxacin Otic
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- Alejandro Hoberman
Infections, Streptococcal
A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of…
- Trial name
- NCT02447432
- Testing
- Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation), Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation), DTPw-HBV/Hib
- Where
- Bangladesh
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Otitis Media, Acute Sinusitis
Comparative Effectiveness of Antibiotics for Respiratory Infections
The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.
- Conditions
- Acute Otitis Media, Acute Sinusitis, Group A Streptococcal Pharyngitis
- Trial name
- CEARI (NCT02297815)
- Testing
- Broad-spectrum antibiotics, Narrow-spectrum antibiotics
- Where
- United States
- Volunteers
- 2,472 people
- Sponsor
- Children's Hospital of Philadelphia