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Otitis clinical trials

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NCT ID: NCT02723890 Completed - Pharyngitis Clinical Trials

The Efficacy and Safety of Using the Novel Tyto Device

Start date: July 2016
Phase: N/A
Study type: Interventional

To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians.

NCT ID: NCT02719158 Completed - Acute Otitis Media Clinical Trials

Dose Ranging Study of OTO-201 in AOMT

Start date: February 2016
Phase: Phase 2
Study type: Interventional

Dose Ranging Study of OTO-201 in AOMT

NCT ID: NCT02716376 Completed - Hearing Loss Clinical Trials

Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy

Start date: April 2016
Phase: N/A
Study type: Interventional

To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.

NCT ID: NCT02630992 Completed - Acute Otitis Media Clinical Trials

Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media

Start date: December 2015
Phase: Phase 3
Study type: Interventional

To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.

NCT ID: NCT02616458 Completed - Otitis Media Clinical Trials

The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population

Start date: November 2010
Phase: N/A
Study type: Interventional

Importance: Ear pain is a frequent reason for pediatric visits. Objective: To determine if a program of anticipatory guidance counseling for ear pain at the 12-15 month routine preventive care visit in a predominantly low income population can reduce medical visits to clinic, emergency department (ED), and urgent care (UC). Design: Single blind randomized control trial of an ear pain counseling program. Setting: The Child Health Clinic (CHC), a primary care clinic at Children's Hospital Colorado, which serves a predominantly low income population with diverse cultural and ethnic backgrounds. Participants: 310 mothers were enrolled at their child's 12-15 month well child visit. Intervention: Structured 10-minute education intervention, given by a research assistant, used a slide presentation that reviewed ear pain Main Outcome and Measures: Number of ED, UC, and clinic visits for otitis media for the 12 month period after entry into the study and whether the visit included a prescription for antibiotics.

NCT ID: NCT02610699 Completed - Otitis Clinical Trials

Community Pediatric Acceptability Study (CPAS)

CPAS
Start date: November 2014
Phase: N/A
Study type: Interventional

Ear infections, or otitis media, are a leading cause of health expenditures and antimicrobial prescriptions in children. Diagnosis of otitis media requires the ability to view the tympanic membrane. An instrument called an otoscope with a light source and a magnifying lens with a plastic tip that conforms to the ear canal is currently the standard of care for examining the tympanic membrane. Interpretation of otoscopic examinations is operator-dependent and cannot be seen by anyone other than the person holding the otoscope. A pocket size attachment that uses the technology and light source of a smartphone to capture images of the ear canal and tympanic membrane facilitates image documentation of the otic examination. In previous studies with the device, the investigators have shown that image quality of photographs of the tympanic membrane taken with the smartphone otoscope are equivalent to those taken with a camera-fitted conventional otoscope. In this study, the Community Provider Assessment Study (CPAS), the investigators will perform a cross-sectional study in which they will randomly assign 3-4 pediatricians to use a smartphone otoscope as the standard of care device for all ear examinations and 3-4 pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months. The parents of children examined during the study period with both devices will be invited to participate in 3 telephone surveys assessing parental satisfaction with the device and antimicrobial use by their child for the otic complaint. The results of this study have the potential to improve diagnosis and management of otitis media, thus improving patient care, reducing costs, and decreasing the opportunity for the development of antimicrobial resistance.

NCT ID: NCT02600559 Completed - Otitis Media Clinical Trials

Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Start date: October 2015
Phase: Phase 3
Study type: Interventional

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. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

NCT ID: NCT02592382 Completed - Otitis Media Clinical Trials

Nasal Xylitol in the Prevention of Otitis Media

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Acute otitis media (AOM) is one of the most prevalent and costly illnesses in children throughout the world. AOM can lead to chronic otitis media with effusion (OME) resulting in conductive hearing loss that can cause speech, language, academic, and social developmental delays. Complementary and alternative medicines are being widely used for prevention of AOM. Xylitol is a five carbon polyol (sugar alcohol) produced from natural plants and is used for preventing dental caries and AOM in children. It is commercially available in chewing gums, syrups and toothpastes washes, and other products. Xylitol was shown in several studies to prevent the culture of bacteria in the nasopharynx and oral cavity. It was proven to eliminate the ability of bacteria to attach to the mucosa of the upper respiratory system. It was proven to reduce the ability of bacteria to attach to the mucosa of the upper respiratory system. Previous study had shown that oral usage of Xylitol (as chewing gum or syrup) can reduce the incidence of rAOM by 30% as compared to placebo. But this treatment did not gain popularity since the initial clinical trial 30 years. There are several potential reasons for that. First, Xylitol should be administrated 5 times daily in order to be effective. Study that checked usage of oral Xylitol 3 times daily in children with rAOM did not find additional advantage as compared to placebo. Secondly, by using Xylitol orally we rely on the gut absorption and systemic distribution. Xylitol absorbs poorly in the gut and can cause some GI symptoms (like nausea and diarrhea) especially when used in a syrup (the preferred way in small children). In this study the investigators aim to test the yield of Xylitol nasal spray as a preventive treatment in children with rAOM. By using Xylitol as nasal spray we deliver the active compound directly to the action site (nasopharynx- the AOM reservoir) and avoid the GI side effects

NCT ID: NCT02592096 Recruiting - Otitis Media Clinical Trials

Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

Start date: July 2015
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT02591563 Active, not recruiting - Clinical trials for Nasopharyngeal Colonization and Acute Otitis Media

Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

AOM
Start date: October 2015
Phase:
Study type: Observational

The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.