Clinical trials: Otitis Media Acute
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.
Otitis Media
Effect of Prevnar 13 on Ear Infections in Children
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.
- Trial name
- NCT01199016
- Testing
- Tympanocentesis, Nose/throat swab, Observational
- Where
- 7 sites in United States
- Volunteers
- 239 people
- Sponsor
- Pfizer
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
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.
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
Acute Otitis Media
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.
- Trial name
- NCT01908803
- Testing
- AL-60371/AL-817 otic suspension, Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
- Volunteers
- 84 people
- Sponsor
- Alcon Research
Acute Otitis Media
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6…
- Trial name
- NCT00645112
- Testing
- cefdinir (Omnicef), azithromycin
- Where
- 30 sites in United States
- Volunteers
- 357 people
- Sponsor
- Abbott
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.
Acute Otitis Media
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice…
- Trial name
- NCT00643292
- Testing
- amoxicillin/clavulanate postassium (Augmentin ES-600), azithromycin SR
- Where
- 48 sites in United States, Argentina and 11 more
- Volunteers
- 902 people
- Sponsor
- Pfizer
Urinary Tract Infection, Diabetes Mellitus
Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station
The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station to…
- Conditions
- Urinary Tract Infection, Diabetes Mellitus, Atrial Fibrillation, OSA
- Trial name
- NCT02856633
- Testing
- Vitaliti
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cloud DX Inc.
Otitis Media, Infections, Respiratory Tract
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses.
- Conditions
- Otitis Media, Infections, Respiratory Tract, Respiratory Tract Infections
- Trial name
- NCT04600752
- Testing
- Augmentin (ES)-600
- Where
- 13 sites in India
- Volunteers
- 310 people
- Sponsor
- GlaxoSmithKline
Pain, Acute Otitis Media
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media
To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media.
- Trial name
- NCT02092454
- Testing
- Benzocaine
- Where
- 3 sites in United States
- Volunteers
- 65 people
- Sponsor
- Otic Therapy, LLC
Pain, Acute Otitis Media
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.
- Trial name
- NCT03116737
- Testing
- Benzocaine Otic Solution
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- Lachlan Pharma Holdings
Infections, Streptococcal
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey
The purpose of this study is to identify and characterize the bacteria causing complicated Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey.
- Trial name
- NCT01031329
- Testing
- Tympanocenthesis and urine collection
- Where
- 8 sites in Turkey (Türkiye)
- Sponsor
- GlaxoSmithKline
Otitis Media, Suppurative, Otitis Media, Purulent
TELI COM - Telithromycin in Children With Otitis Media
This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age]) with AOM.Subjects will be randomized to receive…
- Trial name
- NCT00315003
- Testing
- Telithromycin, Azithromycin
- Where
- 13 sites in United States, Argentina and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Sanofi
Otitis Media
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Assess tolerability of different dosing formulations (adult versus pediatric).
- Trial name
- NCT00360100
- Testing
- Zmax
- Where
- 10 sites in United States, Argentina and 5 more
- Volunteers
- 120 people
- Sponsor
- Pfizer
Otitis Media With Effusion, Acute Otitis Media
Evaluation of the Tympanostomy Tube Delivery System
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
- Trial name
- inVENT-OR (NCT01202578)
- Testing
- tympanostomy tube
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Integra LifeSciences Corporation
Acute Otitis Media
Bio-Kult Infantis® in AAD Prevention in Infants
Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the intestinal mucosa associated to the administration of antibiotics.
- Trial name
- NCT03516409
- Testing
- Biokult
- Where
- Italy
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Probiotics International Ltd.
Acute Otitis Media
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.
- Trial name
- NCT01404611
- Testing
- DF289, DF277, DF289 plus DF277
- Where
- Spain
- Volunteers
- 331 people
- Sponsor
- Salvat
Acute Otitis Media
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses…
- Trial name
- NCT00644943
- Testing
- cefdinir (Omnicef), amoxicillin
- Where
- 32 sites in United States
- Volunteers
- 425 people
- Sponsor
- Abbott