Infectious otitis media

Summary

Infectious otitis media (MONDO:0024330) is a disease and 181 clinical trials. Top therapeutic interventions include amoxicillin, cefdinir, and clavulanic acid. A subtype of otitis media — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Clinical trials: 181

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	infectious otitis media
Mondo ID	MONDO:0024330
NCIT	C84354
UMLS	C2827407
MedGen	443472
Is cancer (heuristic)	no

Also known as: acute otitis Media · AOM · infectious otitis Media · middle Ear infection · otitis media

Data availability: 4 cell lines.

Disease family

This is a subtype of otitis media. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by body system or component › auditory system disorder › middle ear disorder › otitis media › infectious otitis media

Related subtypes (7): middle ear cholesterol granuloma, non-suppurative otitis media, otosalpingitis, suppurative otitis media, allergic otitis media, chronic otitis media, tympanitis

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

No druggable-target or therapeutic data for this disease’s cohort.

Clinical trials & evidence

Clinical trials

Clinical trials: 181.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	106
PHASE3	33
PHASE4	18
PHASE2	15
PHASE1	5
PHASE2/PHASE3	2
PHASE1/PHASE2	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03655665	PHASE4	RECRUITING	Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present
NCT07015736	PHASE4	ACTIVE_NOT_RECRUITING	Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)
NCT00189462	PHASE4	COMPLETED	A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
NCT00299455	PHASE4	UNKNOWN	Amoxicillin Clavulanate in Treatment of Acute Otitis Media
NCT00377260	PHASE4	COMPLETED	Acute Otitis Media (AOM) Therapy Trial in Young Children
NCT00393159	PHASE4	UNKNOWN	The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
NCT00419380	PHASE4	COMPLETED	Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
NCT00539149	PHASE4	COMPLETED	Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
NCT00644943	PHASE4	COMPLETED	A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
NCT00645112	PHASE4	COMPLETED	A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
NCT00956748	PHASE4	WITHDRAWN	N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media
NCT01174849	PHASE4	COMPLETED	Pneumococcal Vaccines Early and in Combination
NCT01244126	PHASE4	COMPLETED	Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy
NCT01735084	PHASE4	COMPLETED	Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life
NCT01800747	PHASE4	COMPLETED	Clinical Trial for the Assessment of Delayed Antibiotic Treatment in Pediatric (DAP-Pediatrics)
NCT02653742	PHASE4	UNKNOWN	Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children
NCT02935374	PHASE4	COMPLETED	Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
NCT04600752	PHASE4	COMPLETED	Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
NCT07189572	PHASE3	NOT_YET_RECRUITING	Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma
NCT00000363	PHASE3	COMPLETED	Acute Otitis Media: Adjuvant Therapy to Improve Outcome
NCT00044473	PHASE3	COMPLETED	A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
NCT00051753	PHASE3	COMPLETED	Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
NCT00174811	PHASE3	TERMINATED	Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections
NCT00310349	PHASE3	UNKNOWN	PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease
NCT00360100	PHASE3	COMPLETED	Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
NCT00368823	PHASE3	COMPLETED	A Trial of Point of Care Information in Ambulatory Pediatrics
NCT00378417	PHASE3	COMPLETED	Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
NCT00578474	PHASE3	COMPLETED	A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
NCT00579189	PHASE3	COMPLETED	Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
NCT00581711	PHASE3	COMPLETED	Improving Otitis Media Care With Clinical Decision Support
NCT00638534	PHASE3	COMPLETED	Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
NCT00643292	PHASE3	COMPLETED	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
NCT00645203	PHASE2/PHASE3	COMPLETED	Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
NCT00714064	PHASE3	COMPLETED	PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers
NCT00781521	PHASE3	COMPLETED	Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
NCT01044030	PHASE3	COMPLETED	Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
NCT01071902	PHASE3	TERMINATED	Safety and Efficacy of Moxidex Otic
NCT01202578	PHASE2/PHASE3	COMPLETED	Evaluation of the Tympanostomy Tube Delivery System
NCT01395966	PHASE3	COMPLETED	Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
NCT01404611	PHASE3	COMPLETED	Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
AMOXICILLIN	4	3
CEFDINIR	4	3
CLAVULANIC ACID	4	3
KETOROLAC	4	3
MONTELUKAST	4	3
STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197	4	3
CIPROFLOXACIN	4	2
LEVOFLOXACIN ANHYDROUS	4	2
TELITHROMYCIN	4	2
AZITHROMYCIN	4	1
FENTANYL	4	1
FINAFLOXACIN	4	1
OFLOXACIN	4	1
PIPERACILLIN	4	1
SIMETHICONE	4	1
TERFENADINE	4	1
BENZOCAINE	3	4
XYLITOL	3	3
SYRUP	3	2
ANTIPYRINE	3	1
ECHINACEA, UNSPECIFIED	3	1
FAROPENEM MEDOXOMIL	3	1
POTASSIUM	3	1
CHEMBL1215848	0	2
CHEMBL5205127	0	1
CHEMBL4299381	0	1
CHEMBL4127074	0	1
VEHICLE	0	1