Clinical Trials for Ear Infections

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Ear Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 14
• Active, not recruiting: 6
• Completed: 19
• Other: 11

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04460313 — Nasopharyngeal Carriage of S. Pneumoniae

This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children wit…

NCT04743609 — RSV Burden in Outpatient and Hospital Settings

Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

NCT04812093 — Spectroscopic Evaluation of Middle Ear Infection

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 asses…

NCT05353569 — Coherent Optical Detection of Middle Ear Disease

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 otoscopy will be compared to those made with the addition of OCT.

NCT06023550 — Complicated Infections in Otorhinolaryngology

This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are:

• What is the management of complicated sinonasal infections in Ljubljana, Slovenia,
• What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,
• What is the management of complicated neck soft tissue infections in L…

NCT07335874 — Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening

Cytomegalovirus (CMV) infection is the most common congenital infection. It is the second leading cause of sensorineural hearing loss after genetic causes and the leading cause of motor delay. It can also cause ophthalmological or biological abnormalities (hepatic cytolysis, thrombocytopenia, etc.). Currently, routine screening during pregnancy or at birth is not recommended.

90% of infected i…

NCT07216430 — Safety and Efficacy of wSp Vaccine in Young Children

The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination.

The main questions it aims to answer are:

Does wSp vaccine reduce pneumococcal colonization in the nose? Does wSp vaccine safely stimulate the immune system to produce antibodies …

NCT07500532 — Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma

This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma and ENT conditions. Participants will be assigned to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person…

NCT07271225 — Safety and Efficacy of Ear Acupuncture for Antituberculosis Drug-Related Nausea and Vomiting

This study will look at whether press-needle ear acupuncture can help lower nausea and vomiting caused by antituberculosis medicines in people with pulmonary tuberculosis. Nausea and vomiting are common side effects of tuberculosis treatment, and they can make people stop taking their medicines

When treatment is stopped too early, tuberculosis may not be cured and may become resistant to medic…

NCT07359287 — Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care

Antimicrobial resistance (AMR), considered one of the greatest global threats by the WHO, justifies the development of initiatives to promote appropriate antibiotic use-especially in primary care, where most antibiotics in France are prescribed and where misuse remains common.

We are proposing a cluster-randomized controlled trial to evaluate the effectiveness of a bimodal intervention combini…

NCT06876259 — Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds

Ear infections are common in young children with cold symptoms, but they can be difficult to diagnose due to small ear canals, child movement, and limited viewing time. In this study, investigators will take photos of the eardrums of children 6-24 months of age with upper respiratory symptoms. The photos will be reviewed by imaging software enhanced with artificial intelligence (AI app) to dete…

NCT07525505 — Nigella Sativa Oil for Eczematous Otitis Externa

Eczematous otitis externa is a common inflammatory condition of the external auditory canal characterized by itching, discomfort, discharge, and pain. Topical corticosteroids are widely used for treatment; however, alternative therapies with fewer side effects are of increasing interest.

This study aims to compare the efficacy of Nigella sativa (black seed) oil and mometasone furoate ear drops…

NCT07635368 — Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.

NCT07253311 — Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

“Candida auris is an emerging fungus that can cause severe infections, particularly in hospitalized patients, and is often resistant to multiple antifungal treatments. Rapid and accurate detection of this pathogen is essential to control its spread in healthcare settings.

This study aims to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed b…

Active, Not Recruiting

NCT05741333 — In-Office Clinical Study of the Solo+ TTD

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

NCT06285812 — Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.

NCT06191562 — 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). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tube…

NCT07217002 — Reducing Antibiotic Use by Implementation of Stewardship in Primary and Urgent Care

The goal of this project is to reduce unnecessary antibiotic use for children with ARTIs (Acute Respiratory Tract Infections) by implementing “outpatient antibiotic stewardship” across the Children’s Hospital of Philadelphia (CHOP) Primary and Urgent Care Network to:

1. Reduce unnecessary antibiotic prescribing for the most common infections in children.
2. Reduce unnecessary a) broad-spectrum…

NCT07015736 — 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 media or acute bacterial sinusitis. The trial will also assess the potential of the probiotic to reduce antibiotic-associated diarrhea (AAD), antibiotic associated micr…

NCT07328555 — Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children

Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm.

For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each…

Not Yet Recruiting

NCT07246551 — Gamified Training and AI Support for Improving Ear Infection Diagnosis in Primary Care

Acute otitis media (AOM), or middle ear infection, is one of the most common childhood infections and a leading cause of antibiotic prescribing in primary care. Diagnosing AOM can be challenging, as ear symptoms and eardrum appearances often overlap with mild or transient conditions. This uncertainty may lead to both unnecessary antibiotic use and missed cases requiring treatment, affecting pat…

NCT07454512 — Evaluating Laser Otoscope for Middle Ear Effusion Detection

The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are:

-Accuracy and usability of doctors using laser otoscopes

Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determ…

NCT07625657 — CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes

This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed.

In this study, surgeons will use the CLiKX device to place an ear tube in the patient’s ear. The …

NCT07240649 — Emerging Indications for Hyperbaric Oxygen Treatment

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The re…

NCT07559773 — The ROOT Study: Scaling the ‘Standard of Care Plus’ Obstetric Nutrition Model to Optimize Maternal and Infant Health

The ‘Standard of Care Plus’ (‘PLUS’) model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC).

In 2014, the investigators demonstrated statistically significant reductions in adverse maternal and i…

NCT07665866 — Suivi Prospectif Des ostéomyélites de la Base du crâne

Skull base osteomyelitis (SBO) is a rare and complex infection that includes malignant external otitis and central skull base osteomyelitis.

Symptoms are often non-specific, and the disease typically progresses slowly, leading to delays in diagnosis and treatment, as well as local or regional complications.

Management is not standardized and consists of medical treatment tailored to microbiol…

NCT07639775 — Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media

The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement.

The main question it aims to answer is:

Can a standardized OMT protocol, given on…

NCT07640568 — Parent-led Assessment and Recognition of AOM Using Digital Ear Imaging

Acute otitis media (AOM) is the most common bacterial infection in young children and a major contributor to healthcare utilization and costs. Diagnosis relies on otoscopy and identification of tympanic membrane (TM) bulging, yet physician-performed otoscopy has variable diagnostic accuracy and depends heavily on clinical expertise.

Digital otoscopy combined with artificial intelligence (AI)-b…

Enrolling by Invitation

NCT07567274 — DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury

The goal of this clinical trial is to test a compounded dimethyl sulfoxide (DMSO)-based dual-route therapy for adults with refractory subjective tinnitus linked to long-COVID (post-acute sequelae of SARS-CoV-2) or post-COVID-19 vaccine injury. Participants have bothersome tinnitus that has not improved with at least two prior standard treatments.

All participants will receive two study treatme…

Completed Trials

NCT00023036 — Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts

This study will try to identify and understand the genetic factors that lead to an inner ear malformation called “enlarged vestibular aqueducts”, that can be associated with hearing loss.

Patients with sensorineural hearing loss with or without inner ear malformations and their parents and siblings may be eligible for this study. Participants and their immediate family members, may undergo som…

NCT00419380 — Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. Clogged tu…

NCT02972281 — Systematic Search for Primary Immunodeficiency in Adults With Infections

Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guid…

NCT02558738 — Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations

In this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.

NCT06100159 — Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion

The goal of this clinical, randomized trial is to compare the sleeping patterns and quality of life of children with chronic otitis media with effusion (OME) with or without tympanic tubes insertion. The main questions it aims to answer are:

• Does tympanic tube insertion have an effect on sleep quality in children with chronic OME?
• Does tympanic tube insertion improve the quality of life fo…

NCT04193215 — V114 and Acute Otitis Media (V114-032/PNEU-ERA)

The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.

NCT05994768 — 18F-FDG Tomography and Labeled Leukocyte Scintigraphy

The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

NCT07254442 — Investigation of the Impact of Medications Used in COVID-19 Treatment and COVID-19 Vaccine on Hearing

Investigation of the Impact of Medications Used in COVID-19 Treatment and COVID-19 Vaccine on Hearing

NCT05127161 — Broad Implementation of Outpatient Stewardship

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…

NCT05660382 — Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

The goal of this clinical trial is to prove the that miconazole oil works well on fungal infections of the ears, by comparing the drug with a placebo. The researcher or the participants will not know if they are getting the drug or the placebo. The researcher will show the participants how to use the drug or placebo. After 14 days of using the drug or placebo, the participants will be examined …

NCT07664319 — Effect of Platelet-Rich Plasma on Eardrum Healing and Hearing After Tympanoplasty in Adults

This single-center controlled trial evaluated whether intraoperative application of autologous platelet-rich plasma (PRP)-impregnated absorbable gelatin sponge improves graft take rates and audiological outcomes in adults undergoing tympanoplasty for chronic otitis media with tympanic membrane perforation. Forty-eight patients were allocated by systematic alternation to a PRP group (PRP-impregn…

NCT06967506 — Evaluation of Blowing Exercises Utilizing a Breathing Exercise Device in Otitis Media With Effusion

Otitis media with effusion (OME) is a common condition in which fluid collects behind the eardrum without signs of infection. It can cause hearing problems and discomfort. Many children get better with medication, but in some cases, the condition becomes long-term and may require surgery.

OME is caused by dysfunction of the Eustachian tube, which helps balance the air pressure between the midd…

NCT05666505 — Evaluation of a New mHealth Tympanometer

Children in rural and underserved communities experience a disproportionately high burden of infection-related hearing loss, which is often preventable with timely identification and follow-up care. A tympanometer is a device that evaluates the health of the middle ear but is often not used in screening programs due to barriers of high cost and need for trained professionals such as audiologist…

NCT07535424 — Comparative Efficacy of Topical Clotrimazole Versus 2% Salicylic Acid in Otomycosis

Otomycosis is a fungal infection of the outer ear canal that commonly causes itching, discomfort, discharge, and a feeling of blockage in the ear. This randomized controlled study was conducted to compare two commonly used topical treatments for otomycosis: clotrimazole ear drops and 2% salicylic acid ear drops. A total of 60 patients diagnosed with otomycosis were enrolled and were randomly as…

NCT07295210 — Boric Acid Versus 10% Povidone Iodine Solution in Treatment of Otomycosis

This study compares two topical agents for the treatment of fungal infection of the external auditory canal: boric acid and a 10% povidone-iodine solution

NCT06731660 — Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children

Randomized controlled trial involving 40 pediatric primary care clinicians with high rates of diagnosing and treating middle ear infections. Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month trial: 1) personalized education and feedback about proper ear infection diagnosis; 2) use of a digital otoscope; 3) both education and feedback plus use of a digital oto…

NCT07595484 — A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty

This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is…

NCT07242001 — Laser Acupuncture for Otitis Media With Effusion in Children

The goal of this clinical trial is to learn if laser acupuncture (LA) can improve middle ear function and reduce the recurrence of Otitis Media with Effusion (OME) in children. The main questions it aims to answer are:

Does LA, when combined with standard treatment (decongestants), improve middle ear function as measured by tympanometry immediately after the 2-week intervention? Does LA, when …

NCT07535827 — Insulin Intratympanic Application

The objective of the present study was to study the impact of insulin insitu-gel formulation on healing progress after surgical procedures for treatment of dry tympanic membrane perforation for at least three consecutive months. At the beginning, an insulin insitu-gel was prepared from three different polymers compatible with insulin physiochemically and reported to be vain on insulin efficacy …

Other (Terminated)

NCT03655665 — Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present

To determine whether the use of topical otic drops intra-operative and post-operative during tympanostomy tube placement reduces the rate of tympanostomy tube occlusion and post-operative otorrhea (ear drainage) during the initial 4-week post-operative period in subjects with no middle ear effusion (fluid behind the ear drum) present at the time of surgery. A within subject controlled study des…

NCT05229744 — Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection

The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.