Clinical trials: Otitis Media Acute
Middle Ear Effusion, Tympanic Membrane Perforation
PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease
PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants.
- Conditions
- Middle Ear Effusion, Tympanic Membrane Perforation, Acute Otitis Media, Pneumococcal Infections
- Trial name
- NCT00310349
- Testing
- 23 valent pneumococcal polysaccharide vaccine
- Where
- Australia
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- University of Melbourne
Acute Otitis Media
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses…
- Trial name
- NCT00644943
- Testing
- cefdinir (Omnicef), amoxicillin
- Where
- 32 sites in United States
- Volunteers
- 425 people
- Sponsor
- Abbott
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
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
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
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
Acute Otitis Media, Pain
Analgesic Ear Drops for Children With Acute Otitis Media
This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM.
- Trial name
- OPTIMA (NCT05651633)
- Testing
- lidocaine hydrochloride 5mg/g
- Where
- Netherlands
- Volunteers
- 29 people
- Sponsor
- UMC Utrecht
Acute Otitis Media
Bio-Kult Infantis® in AAD Prevention in Infants
Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the intestinal mucosa associated to the administration of antibiotics.
- Trial name
- NCT03516409
- Testing
- Biokult
- Where
- Italy
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Probiotics International Ltd.
Pain, Acute Otitis Media
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.
- Trial name
- NCT03116737
- Testing
- Benzocaine Otic Solution
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- Lachlan Pharma Holdings
Acute Otitis Media
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence…
- Trial name
- NCT01044030
- Testing
- Xylitol syrup
- Where
- 2 sites in United States
- Volunteers
- 326 people
- Sponsor
- Boston Children's Hospital
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
Upper Respiratory Infection, Acute Bacterial Sinusitis
Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison
Findings from an ongoing improvement project to improve antibiotic prescribing for children and adolescents for three acute respiratory tract infections (ARTIs: upper respiratory tract infection, acute bacterial sinusitis, and…
- Conditions
- Upper Respiratory Infection, Acute Bacterial Sinusitis, Acute Otitis Media
- Trial name
- NCT04588376
- Testing
- Peer comparison feedback monthly
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Herb Clegg
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
Otitis Media
Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life.
- Trial name
- COMIT1 (NCT00539149)
- Testing
- Amoxycillin
- Where
- Australia
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
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 of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome.
- Trial name
- NCT01511107
- Testing
- Amoxicillin-Clavulanate, 10 days, Amoxicillin-Clavulanate, 5 days
- Where
- 2 sites in United States
- Volunteers
- 520 people
- Sponsor
- Alejandro Hoberman
Antibiotic Associated Diarrhea, Acute Otitis Media
Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)
This study aims to evaluate the effect of co-administering the probiotic Saccharomyces boulardii CNCM I-745 with amoxicillin-clavulanic acid on the intestinal and nasopharyngeal microbiota in children diagnosed with acute otitis…
- Conditions
- Antibiotic Associated Diarrhea, Acute Otitis Media, ACUTE SINUSITIS
- Trial name
- RESTORE (NCT07015736)
- Testing
- Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension, Saccharomyces boulardii CNCM I-745
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eskisehir Osmangazi University
Acute Otitis Media
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
The investigators seek to conduct a prospective, longitudinal study to identify the dynamic changes in nasopharyngeal (NP) colonization patterns and acute otitis media (AOM) etiology involving antibiotic-resistant Streptococcus…
- Trial name
- AOM (NCT04946084)
- Testing
- Tympanocentesis, Nasal Phalangeal Swab and Wash, Blood Draw
- Where
- United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Rochester General Hospital
Otitis Media in Children, Chronic Otitis Media With Effusion
Posterior vs. Anterior Tympanostomy Tube Placement
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants).
- Conditions
- Otitis Media in Children, Chronic Otitis Media With Effusion, Recurrent Acute Otitis Media
- Trial name
- NCT06191562
- Testing
- Tympanostomy tube
- Where
- 2 sites in United States
- Volunteers
- 386 people
- Sponsor
- David Chi, MD
Acute Otitis Media
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice…
- Trial name
- NCT00643292
- Testing
- amoxicillin/clavulanate postassium (Augmentin ES-600), azithromycin SR
- Where
- 48 sites in United States, Argentina and 11 more
- Volunteers
- 902 people
- Sponsor
- Pfizer