Clinical trials: Acute Otitis Media
- Condition Acute Otitis Media
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Upper Respiratory Tract Infections
LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media
Acute respiratory tract infections (ARTIs), such as acute rhinosinusitis (ARS) and acute otitis media (AOM), are common worldwide and caused by viruses or bacteria entering the body through the mouth and nose.
- Trial name
- NCT05804123
- Testing
- 0.9% NaCl physiological saline Nasal-spraying, LiveSpo Navax®, Augmentin 500Mg Tablet
- Where
- Vietnam
- Volunteers
- 175 people
- Sponsor
- Anabio R&D
Infections, Streptococcal
Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged…
- Trial name
- NCT01545375
- Testing
- Pneumococcal vaccine GSK2189242A, Prevnar 13®, PedvaxHIB®
- Where
- 5 sites in United States
- Volunteers
- 1,806 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pain, Otitis Media
Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.
- Trial name
- NCT01588535
- Testing
- benzocaine
- Where
- 15 sites in United States
- Volunteers
- 38 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Ear Infection, Otitis Media
Clinical Study of the Solo Tympanostomy Tube Device
The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy…
- Trial name
- NCT03722160
- Testing
- Solo TympanostomyTube Device
- Where
- 3 sites in Italy, United Kingdom
- Volunteers
- 27 people
- Sponsor
- AventaMed DAC
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
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.
- Trial name
- NCT00645203
- Testing
- cefdinir
- Where
- 22 sites in United States, Chile and 5 more
- Volunteers
- 447 people
- Sponsor
- Abbott
Otitis Media, Otitis Media With Effusion
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
The aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.
- Conditions
- Otitis Media, Otitis Media With Effusion, Pneumococcal Infections
- Trial name
- NCT00195611
- Testing
- Prevenar
- Where
- 35 sites in France
- Volunteers
- 3,293 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Acute Otitis Media
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
- Trial name
- NCT01214538
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- NasVax Ltd
Otitis Media
Singapore Tympanostomy Tube Delivery System Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis…
- Trial name
- NCT01046877
- Testing
- Tympanostomy Tube Delivery System
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Otitis Media
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear.
- Trial name
- NCT02600559
- Testing
- OTO-201 (ciprofloxacin)
- Where
- United States
- Volunteers
- 501 people
- Sponsor
- Otonomy, Inc.
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Media
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan
The purpose of the study is to identify the bacterial aetiology of Acute Otitis Media episodes in young children aged >= 3 months to < 5 years in Taiwan
- Trial name
- NCT01072227
- Testing
- Sample Collection
- Where
- 2 sites in Taiwan
- Volunteers
- 10 people
- Sponsor
- GlaxoSmithKline
Otitis Media
Clinical Evaluation of the OtoSight
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media.
- Trial name
- NCT03890107
- Testing
- OtoSight Middle Ear Scope
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- PhotoniCare, Inc.
Otitis Media, Middle Ear Infections
Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device
The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the…
- Trial name
- NCT07029997
- Testing
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- AventaMed DAC
Acute Otitis Media, Mastoiditis
Impact 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
- NCT01272999
- Testing
- No intervention
- Where
- 8 sites in United States
- Volunteers
- 391 people
- Sponsor
- Pfizer
Otitis Media With Effusion, Middle Ear Effusion
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
The study has three objectives: 1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy) 2.
- Trial name
- NCT01421199
- Testing
- Myringotomy
- Volunteers
- 125 people
- Sponsor
- OtoSonics Inc.
Otitis Media
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
- Trial name
- inVENT2 (NCT02150044)
- Testing
- Acclarent Tympanostomy Tube Delivery System (TTDS).
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Acute Otitis Media
Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
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
- AR01006 (NCT02044341)
- Testing
- AR01, Glycerin ear drops
- Where
- 29 sites in United States
- Volunteers
- 304 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Otitis Media Acute
Clinical Development of Deep Learning for the OtoSight
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the…
- Trial name
- NCT04722770
- Testing
- PhotoniCare OtoSight Middle Ear Scope
- Where
- United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- PhotoniCare, Inc.
Otitis Media
Hummingbird TTS Ear Tube Delivery Study
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
- Trial name
- NCT02165384
- Testing
- Ear tube placement with the Hummingbird TTS
- Where
- 4 sites in United States
- Volunteers
- 199 people
- Sponsor
- Preceptis Medical, Inc.