Clinical trials: Otitis
Acute Otitis Media
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
The purpose of this study is to identify and characterize the bacteria causing acute otitis media episode in HIV-positive and HIV-negative children (>=3 months to <5 years) in South Africa.
- Trial name
- NCT01031082
- Testing
- Middle ear fluid, nasopharyngeal aspirate and urine sample.
- Where
- South Africa
- Volunteers
- 265 people
- Sponsor
- GlaxoSmithKline
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
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
Ear Infection, Otitis Media
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.
- Trial name
- NCT03544138
- Testing
- Hummingbird Tympanostomy Tube System (H-TTS)
- Where
- 7 sites in United States
- Volunteers
- 258 people
- Sponsor
- Preceptis Medical, Inc.
Acute Otitis Media (AOM)
Safety and Efficacy of wSp Vaccine in Young Children
The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination.
- Trial name
- wSp005 (NCT07216430)
- Testing
- wSp vaccine, Saline (0.9% NaCl)
- Where
- 7 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Pneumonia, Bacterial
Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children
Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes
- Trial name
- NCT00724828
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Acute Otitis Media
Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus salivarius PS7 on Acute Otitis Media (AOM) in children with recurrent AOM…
- Trial name
- PROMAR (NCT03614117)
- Testing
- Lactobacillus salivarius PS7 during 6 months, Lactobacillus salivarius PS7 during 3 months
- Where
- Spain
- Volunteers
- 222 people
- Sponsor
- ProbiSearch SL
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
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
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
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
- Trial name
- NCT00578773
- Testing
- Moxidex otic solution, Moxifloxacin otic solution, Tympanostomy tubes
- Volunteers
- 303 people
- Sponsor
- Alcon Research
Otitis Media
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM).
- Trial name
- NCT00638534
- Testing
- Telithromycin (HMR3647)
- Where
- Japan
- Volunteers
- 56 people
- Sponsor
- Sanofi
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
Acute Otitis Media
Clinical Study to Assess the 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 the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.
- Trial name
- NCT01395966
- Testing
- DF289, DF277, DF289 plus DF277
- Where
- Spain
- Volunteers
- 331 people
- Sponsor
- Salvat
Acute Otitis Media, AOMT
Dose Ranging Study of OTO-201 in AOMT
Dose Ranging Study of OTO-201 in AOMT
- Trial name
- NCT02719158
- Testing
- 6 mg ciprofloxacin, 12 mg ciprofloxacin
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Otonomy, Inc.
Otitis Externa
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in…
- Trial name
- NCT00980876
- Testing
- Cipro HC, Ciprofloxacin HCl and Hydrocortisone
- Where
- Brazil
- Volunteers
- 224 people
- Sponsor
- Farmoquimica S.A.
Acute Otitis Externa
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
- Trial name
- NCT01535560
- Testing
- AL-60371, 0.3% otic suspension, AL-60371 Vehicle
- Volunteers
- 589 people
- Sponsor
- Alcon Research
Otitis Media
Tympanostomy Tube Placement in Children in the Office (Inova Study)
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
- Trial name
- Inova (NCT01496287)
- Testing
- Tube Delivery System (TDS)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Integra LifeSciences Corporation
Acute Otitis Externa
Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of…
- Trial name
- NCT02216071
- Testing
- Ciprodex®, EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 499 people
- Sponsor
- Exela Pharma Sciences, LLC.
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.