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Otitis Media clinical trials

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NCT ID: NCT05361239 Recruiting - Clinical trials for AOM - Acute Otitis Media

Delayed Antibiotic Therapy in General Practice

ADOMA
Start date: October 20, 2022
Phase:
Study type: Observational

Introduction In 2019, France was the 4th highest consumer of antibiotics in Europe. Among the interventions proposed to reduce antibiotic prescribing, delayed prescribing deserves particular attention. The effectiveness of delayed antibiotic prescription in reducing antibiotic consumption remains poorly studied in the literature, and no study has yet been conducted in France. The main objective of our study is to investigate the factors associated with the choice of antibiotic strategy(immediate or deferred). The secondary objectives are to study the frequency and factors associated with antibiotic consumption according to the initial prescription, and to determine the typical profiles of patients, in the context of a delayed prescription, who consume the antibiotic outside the GP's recommendations. Method 330 general practitioners in Ile-de-France will recruit 2800 patients older than 6 months with acute otitis media between September 2022 and March 2023. GPs will be recruited via the CNGE investigator network, the colleges of general medicine in Ile-de-France, the Sentinelles network, the French Medical Association and the regional unions of health professionals. Initial medical data will be collected by the physicians. Patients will fill in daily data for 2 weeks to monitor their disease. They will also fill in social data, and questionnaires assessing their level of health literacy, confidence and satisfaction with the general practitioner consulted. Factors associated with the physician's choice of antibiotic therapy and the patients' consumption of antibiotics will be analyzed via mixed models. Consumption rates will be expressed as percentages with their confidence intervals. Conclusion This work will allow a better understanding of the elements that guide physicians towards delayed prescription. It can help physicians to better assess patients who are likely to be non-compliant with delayed prescription in order to avoid this type of prescription for them.

NCT ID: NCT05353569 Recruiting - Otitis Media Clinical Trials

Coherent Optical Detection of Middle Ear Disease

OCTII
Start date: May 24, 2022
Phase: N/A
Study type: Interventional

The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely pneumatic otoscopy (PO) will be compared to those made with the addition of OCT.

NCT ID: NCT05348291 Recruiting - Clinical trials for Recurrent Acute Otitis Media

Effect of Ventilation Tubes in Otitis-prone Children

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of ventilation tubes in children with recurrent ear infections. By drawing lots, young children with recurrent ear infections will be assigned to one of two groups (ventilation tubes or close follow-up), and the number of ear infections and antibiotic prescriptions in each group will be monitored. The study participants will be followed until they are 7 years old.

NCT ID: NCT05324696 Recruiting - Hearing Loss Clinical Trials

Autoinflation: Alternative in the Treatment of Otitis Media With Effusion

OME
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Otitis media with effusion (OME) is a common finding affecting children and the main cause of acquired hearing loss in the pediatric age. OBJECTIVES The purpose of the clinical study is to determine whether self-inflation using a new device: - It is an effective non-invasive treatment during the watchful waiting period, with the ability to improve hearing loss and prevent surgical treatment; - Maintains long-term hearing improvement;

NCT ID: NCT05133258 Completed - Clinical trials for Chronic Suppurative Otitis Media

Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media

Start date: July 5, 2022
Phase:
Study type: Observational

The study team aims to elucidate the potential role of ototopical antibiotic concentration on outcomes in patients diagnosed with chronic suppurative otitis media (CSOM). Chronic suppurative otitis media (CSOM) is characterized by chronic inflammation of the middle ear with persistent discharge from a non-intact tympanic membrane. CSOM is notably associated with a significant burden of disease worldwide. Topical fluoroquinolones are first line therapy for CSOM and are advantageous as compared to oral or intravenous therapy in that these antibiotics avoid systemic side effects and have the potential to locally deliver high antibiotic concentrations, which were thought to be sufficient to overcome all bactericidal resistance to fluoroquinolones. The investigators will measure antibiotic concentration in aspirates via liquid chromatography with tandem mass spectrometry (LC-MS/MS) from the middle ear of selected subjects with CSOM who are prescribed and instructed to self-administer ototopical ciprofloxacin. Enrolled subjects will be asked to return 3 to 10 days after initial visit to aspirate the middle ear and receive a follow-up evaluation. Furthermore, the subjects will be asked to keep logs of their medication use and to administer the ototopical medication one hour prior to their appointments. The measured ciprofloxacin concentrations will be correlated with clinical outcomes, primarily the time to symptom resolution. The guiding hypothesis is that patient self-administration of ciprofloxacin drops vary in antibiotic delivery with diluted concentrations significantly below the in vitro concentration of the prescribed solution and that these concentrations are below the bactericidal concentration of ciprofloxacin-resistant bacteria.

NCT ID: NCT05127161 Active, not recruiting - Otitis Media Clinical Trials

Broad Implementation of Outpatient Stewardship

BIOS
Start date: October 31, 2022
Phase: N/A
Study type: Interventional

Reducing inappropriate antibiotic use is a key strategy to mitigate antibiotic resistance and adverse health effects associated with antibiotic exposure. The Broad Implementation of Outpatient Stewardship (BIOS) project focuses on broadly implementing an evidence-based intervention to improve antibiotic prescribing for acute respiratory tract infections in pediatric outpatient settings. Primary aims include: (1) examining the acceptability, feasibility and utility of a focused implementation strategy on improving intervention adoption and impact and (2) measuring the effectiveness of the intervention to reduce unnecessary broad-spectrum antibiotic prescription.

NCT ID: NCT05086718 Recruiting - Clinical trials for Tympanic Membrane Perforation

Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation

NCT ID: NCT04946084 Active, not recruiting - Acute Otitis Media Clinical Trials

Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens

AOM
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

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 pneumoniae (Spn) and Haemophilus influenzae (Hflu).

NCT ID: NCT04864912 Completed - Clinical trials for Chronic Otitis Media

Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery

Start date: February 1, 2022
Phase:
Study type: Observational

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 loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.

NCT ID: NCT04812093 Recruiting - Clinical trials for Middle Ear Infection

Spectroscopic Evaluation of Middle Ear Infection

Start date: February 26, 2021
Phase:
Study type: Observational

Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.