Clinical trials: Middle Ear Infection
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
Acute Otitis Media, Chronic Otitis Media
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane…
- Conditions
- Acute Otitis Media, Chronic Otitis Media, Recurrent Acute Otitis Media
- Trial name
- IONTO (NCT00941993)
- Testing
- Iontophoresis System (Acclarent)
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Integra LifeSciences Corporation
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
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.
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
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.
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
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
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
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, 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
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
Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.
- Trial name
- NCT03766373
- Testing
- Drug: OP0201 20mg
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Novus Therapeutics, Inc
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
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
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.
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
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
Otitis Media
inVENT-visIOn Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an…
- Trial name
- inVENT-visIOn (NCT01444391)
- Testing
- Tympanostomy tube placement (Acclarent iontophoresis device)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Integra LifeSciences Corporation
Infections, Streptococcal
COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine
This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to…
- Trial name
- NCT00466947
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Havrix, Engerix-B
- Where
- 22 sites in Argentina, Colombia and 1 more
- Volunteers
- 23,802 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline