Clinical trials: Acute Otitis Media
Acute Otitis Media
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and…
- Trial name
- NCT03818815
- Testing
- OP0201, Amoxicillin-clavulanate
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Novus Therapeutics, 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 With Effusion in Children, Otitis Media Recurrent
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT02539654
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Alcon Research
Chronic Otitis Media
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing…
- Trial name
- NCT04864912
- Testing
- Questionnaires and survey
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 69 people
- Sponsor
- Cochlear
Acute Otitis Media
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric…
- Trial name
- NCT00796224
- Testing
- 60 mg/kg azithromycin ER, 30 mg/kg azithromycin IR
- Where
- 2 sites in Costa Rica
- Volunteers
- 38 people
- Sponsor
- Pfizer
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 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 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
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
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
Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol
To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media
- Trial name
- NCT02592096
- Testing
- 0.1% Pazufloxacin Mesilate Ear Drops, 0.3% Pazufloxacin Mesilate Ear Drops, 0.5% Pazufloxacin Mesilate Ear Drops
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Lee's Pharmaceutical Limited
Ear Infection, Otitis Media
In-Office Clinical Study of the Solo+ TTD
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
- Trial name
- VENTY (NCT05741333)
- Testing
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
- Where
- 7 sites in United States
- Volunteers
- 66 people
- Sponsor
- AventaMed DAC
Bilateral Middle Ear Effusion
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement.
- Trial name
- NCT02350998
- Testing
- OTO-201
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- Otonomy, 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
Otitis Media With Effusion
A Non-invasive Device to Remove Fluid From the Middle Ear
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation. The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from…
- Trial name
- NCT03978195
- Testing
- Non-invasive device for middle ear ventilation
- Volunteers
- 40 people
- Sponsor
- Yuinvent Innovations Ltd.
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
Otalgia, Otitis Media
Validating and AI Software for Assessment of Children With Ear Concerns
The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children.
- Conditions
- Otalgia, Otitis Media, Otitis Media Effusion
- Trial name
- NCT07243093
- Volunteers
- 658 people
- Sponsor
- Glimpse Diagnostics, Inc.
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