Clinical trials: Otitis Media in Children
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
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
Otitis Media
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute…
- Trial name
- NCT00051753
- Testing
- levofloxacin; amoxicillin/clavulanate
- Volunteers
- 1,643 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Otitis Media
Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections
The clinical activity of telithromycin vs. cefuroxime in children with acute infections of the middle ear, ages 6 months to 59 months old will be studied.
- Trial name
- NCT00174811
- Testing
- telithromycin (HMR3647)
- Where
- 2 sites in United States, France
- Volunteers
- 639 people
- Sponsor
- Sanofi
Acute Otitis Media
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.
- Trial name
- NCT02037893
- Testing
- Antipyrine and Benzocaine otic solution, Antipyrine Otic Solution, Benzocaine Otic Solution
- Where
- 10 sites in United States
- Volunteers
- 112 people
- Sponsor
- Currax Pharmaceuticals
Otitis Media, Suppurative, Otitis Media, Purulent
TELI COM - Telithromycin in Children With Otitis Media
This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age]) with AOM.Subjects will be randomized to receive…
- Trial name
- NCT00315003
- Testing
- Telithromycin, Azithromycin
- Where
- 13 sites in United States, Argentina and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Sanofi
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.
Otitis Media, Tonsillitis
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic…
- Conditions
- Otitis Media, Tonsillitis, Pharyngitis, Bronchitis
- Trial name
- DoSe iT (NCT04016051)
- Testing
- Clarithromycin DST (125 mg), Clarithromycin DST (187.5 mg), Clarithromycin DST (250 mg)
- Where
- 20 sites in Germany, Poland
- Volunteers
- 265 people
- Sponsor
- Grünenthal GmbH
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
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 With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02436304
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 404 people
- Sponsor
- Alcon Research
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02432105
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 470 people
- Sponsor
- Alcon Research
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
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
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
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
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.
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
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
Infections, Streptococcal
Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama
The study is a survey aiming to describe the healthcare seeking behaviour of primary caregivers when their child aged 6 months to less than 30 months was suspected to have an episode of acute otitis media in Panama.
- Trial name
- NCT01793857
- Testing
- Data collection
- Where
- 13 sites in Panama
- Volunteers
- 1,330 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline