Clinical trials: Middle Ear Infection
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
Otitis Media
A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
The purpose of the study is to assess the rate of elimination of bacteria by levofloxacin in middle ear fluid of children with a rapid and severe onset of infection and inflammation of the middle ear who are at high risk for…
- Trial name
- NCT00044473
- Testing
- levofloxacin
- Volunteers
- 206 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Acute Otitis Media (AOM), Strep Pharyngitis
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma…
- Conditions
- Acute Otitis Media (AOM), Strep Pharyngitis, Asthma Exacerbation, Pediatric Asthma
- Trial name
- NCT07500532
- Testing
- Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis, Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation, Routine Asthma Management (in-person and telehealth visits)- Control Group
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Medentum Innovations
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
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
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
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
Infections, Streptococcal
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
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 Saudi Arabia.
- Trial name
- NCT01204385
- Testing
- Sample collection
- Where
- Saudi Arabia
- Volunteers
- 66 people
- Sponsor
- GlaxoSmithKline
Acute Otitis Media (AOM)
V114 and Acute Otitis Media (V114-032/PNEU-ERA)
The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion…
- Trial name
- NCT04193215
- Testing
- V114, Pediatric vaccines
- Where
- 13 sites in Thailand
- Volunteers
- 7,119 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Otitis Media With Effusion
Clinical Study of the Tympanostomy Tube Delivery System
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such…
- Trial name
- inVENT (NCT00939796)
- Testing
- Acclarent Tympanostomy Tube Delivery System
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Integra LifeSciences Corporation
Hepatitis A
A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent…
- Trial name
- NCT00119743
- Testing
- undecavalent pneumococcal-protein D conjugate vaccine
- Where
- 41 sites in Czechia, Slovakia
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Recurrent Upper-Respiratory Tract Infections
CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study
The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more…
- Trial name
- NCT01948856
- Testing
- J022X ST
- Where
- 24 sites in Italy, Lithuania and 3 more
- Volunteers
- 1,003 people
- Sponsor
- Pierre Fabre Medicament
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
- NCT01949142
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
OME - Otitis Media With Effusion, AOM - Acute Otitis Media
In-Office Tympanostomy Tube Placement in Children (OTTER)
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
- Trial name
- OTTER (NCT03323736)
- Testing
- Iontophoresis & tube placement, Tube placement
- Where
- 19 sites in United States, Canada
- Volunteers
- 370 people
- Sponsor
- Tusker Medical
Otitis Media in Patients With Tympanostomy Tubes
Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX®…
- Trial name
- NCT01994642
- Testing
- Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension, CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
- Where
- 23 sites in United States
- Volunteers
- 203 people
- Sponsor
- Par Pharmaceutical, Inc.
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.
Infections, Streptococcal
To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries
The aim of this study is to provide baseline acute otitis media data in East European countries.
- Trial name
- NCT01365390
- Testing
- Data collection (Retrospective), Data collection (Prospective)
- Where
- 25 sites in Estonia, Lithuania and 3 more
- Volunteers
- 2,258 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Otitis Media
A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
- Trial name
- NCT00578474
- Testing
- Moxidex otic solution, Ofloxacin otic solution, Tympanostomy tubes
- Volunteers
- 911 people
- Sponsor
- Alcon Research
Otitis Media
Study of the Hummingbird TTS™ Tympanostomy Tube System
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under…
- Trial name
- NCT03503591
- Testing
- Hummingbird Tympanostomy Tube System
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- Preceptis Medical, Inc.