Clinical trials: Ear Infection
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
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 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, 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
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
Otitis Media
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
- Trial name
- NCT00768534
- Where
- Germany
- Volunteers
- 2,138 people
- Sponsor
- Pfizer
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 the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
- Trial name
- NCT01535599
- Testing
- AL-60371, 0.3% Otic Suspension, AL-60371 Vehicle
- Volunteers
- 768 people
- Sponsor
- Alcon Research
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 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.
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 (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
Infections, Streptococcal
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.
- Trial name
- NCT01160055
- Testing
- Middle ear fluid and urine.
- Sponsor
- GlaxoSmithKline
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
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 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 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.
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Acute Otitis Externa
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
- Trial name
- NCT03196973
- Testing
- DF289 plus DF277, DF289, DF277
- Where
- Spain
- Volunteers
- 493 people
- Sponsor
- Salvat
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
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