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Otitis clinical trials

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NCT ID: NCT03277820 Completed - Probiotics Clinical Trials

Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion

Start date: April 3, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether the microbiota in the upper respiratory tract (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.

NCT ID: NCT03197558 Completed - Clinical trials for Eustachian Tube Dysfunction

Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)

ADEPT
Start date: June 27, 2017
Phase: Phase 2
Study type: Interventional

A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting. This study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).

NCT ID: NCT03196973 Completed - Clinical trials for Acute Otitis Externa

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa

Start date: July 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE

NCT ID: NCT03116737 Completed - Pain Clinical Trials

Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children

Start date: January 3, 2017
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03109496 Completed - Healthy Clinical Trials

The URT and Middle Ear Microbiota in Health and During Chronic OME

Start date: April 26, 2017
Phase:
Study type: Observational

This study analyses which bacteria are present in the middle ear space and adjacent upper respiratory tract niches in healthy people and in patients suffering from chronic otitis media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are more common and more abundant in healthy people and to evaluate their potential to protect against bacteria commonly involved in OME and other upper respiratory tract infections. To this end, samples will be collected from both groups (healthy vs OME) and analysed through sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants will be cultivated to isolate bacteria of interest.

NCT ID: NCT03101605 Completed - Ear Infection Clinical Trials

E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children

Start date: June 15, 2017
Phase: N/A
Study type: Interventional

An e-learning module to teach how to evaluate ears in children was recently designed. The aim of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose ear infection in clinical setting.

NCT ID: NCT02935374 Completed - Acute Otitis Media Clinical Trials

Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children

AOMMi
Start date: November 2016
Phase: Phase 4
Study type: Interventional

This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they will be monitored as a separate group. The main outcomes of this trial are the changes in the intestinal microbiome after the treatment.

NCT ID: NCT02918773 Completed - Acute Otitis Media Clinical Trials

Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)

Start date: October 15, 2016
Phase: N/A
Study type: Interventional

Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic membrane including capturing still images and recording video of the ear exam would be beneficial in the diagnosis and management of otic complaints, including acute and chronic otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to manage otic complaints, visualize the tympanic membrane, and support antimicrobial stewardship. This study will be conducted as a randomized control study in two affiliated children's hospital emergency departments. Twenty volunteer clinicians will be randomly assigned to use either a smartphone otoscope or a conventional otoscope for all otic examinations for a 6-month period.

NCT ID: NCT02888457 Completed - Clinical trials for Streptococcus Pneumoniae

Carriage of Streptococcus Pneumoniae in Infants With Acute Otitis Media and in Infants Attending Day-care Centers

Start date: October 2015
Phase: N/A
Study type: Interventional

Rationale In Belgium, a unique situation exists for two reasons: on the one hand, the pneumococcal conjugate vaccine (PCV) program, which started in 2007, has quickly reached high coverage in infants: 3-dose coverage rose from 89 % in 2008 to 96.5 % in 2012 in Flanders and from 80.7 % in 2009 to 89.2 % in 2012 in Wallonia; and on the other hand, serotype coverage has moved from PCV7 (since 2007) to PCV13 (since 2011) and very recently to PCV10 (since July 2015 in Flanders and expected in May 2016 in the French Community). Invasive pneumococcal disease (IPD) surveillance has demonstrated a major impact on PCV13 serotypes in infants < 2 years of age. The impact of the current change in PCV-program is hard to predict, but could eventually result in a re-emergence of serotypes not covered by PCV10 (i.e. 3, 6A and 19A). With this unique situation the foundation was laid for a carriage study during which the nasopharyngeal carriage of Streptococcus pneumonia (Sp) and other common colonizers of the nasopharynx will be studied in infants with acute otitis media (AOM) and in healthy infants attending day-care centers (DCC), two populations with high reported pneumococcal carriage. Young children are an important reservoir and major source of transmission of bacteria to the whole community and thus the preferred population to study nasopharyngeal (NP) carriage. Aim of the study The main aim of this study is to evaluate if changes in the conjugate anti-pneumococcal vaccination program in Belgium have an impact on the nasopharyngeal carriage of Pneumococcus in infants aged 6-30 months suffering from AOM or attending day-care, in order to guide future pneumococcal vaccine program decisions and vaccine development, and to feed AOM treatment guidelines in a PCV-program environment. The study will monitor overall pneumococcal carriage, the serotypes involved and the sensitivity of the isolated strains to antibiotics. In addition, the rhinopharyngeal carriage of other common nasopharyngeal colonizers associated with disease, in particular Haemophilus influenzae, will be studied in order to evaluate if changes in pneumococcal carriage impact on the carriage of those pathogens. In infants with AOM, the study will also monitor the clinical course of the AOM and a second nasopharyngeal sample will be taken in case of antibiotic treatment failure or AOM recurrence to identify any association with the carried pathogen.

NCT ID: NCT02872558 Completed - Acute Otitis Media Clinical Trials

Shared Decision Making in Parents of Children With Acute Otitis Media

Start date: March 26, 2017
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting.