Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Status Completed

Clinical Trial Summary

Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00000363
Study type	Interventional
Source	National Institute on Deafness and Other Communication Disorders (NIDCD)
Contact
Status	Completed
Phase	Phase 3
Completion date	June 2001

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04016051` - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections	Phase 3
Completed	`NCT02452164` - Family MobilePhone Otoscopy in Diagnostics of Otitis Media	N/A
Completed	`NCT01199016` - Effect of Prevnar 13 on Ear Infections in Children	Phase 4
Terminated	`NCT00778063` - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients	N/A
Completed	`NCT00195611` - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media	Phase 4
Recruiting	`NCT03722160` - Clinical Study of the Solo Tympanostomy Tube Device	N/A
Recruiting	`NCT04447521` - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting	`NCT05127161` - Broad Implementation of Outpatient Stewardship	N/A
Completed	`NCT02600559` - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes	Phase 3
Completed	`NCT01444391` - inVENT-visIOn Study	N/A
Enrolling by invitation	`NCT01437436` - The Effect of Obesity on Ventilation Tube Insertion	N/A
Completed	`NCT01003210` - Homeopathic Ear Drops for Otitis Media Study	N/A
Completed	`NCT00768534` - Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media	N/A
Recruiting	`NCT00393159` - The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children	Phase 4
Completed	`NCT00617682` - Maternal Immunization To Prevent Infant Otitis Media	Phase 1/Phase 2
Withdrawn	`NCT00956748` - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media	Phase 4
Withdrawn	`NCT01908764` - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery	Phase 1
Recruiting	`NCT01619462` - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children	Phase 3
Completed	`NCT02616458` - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population	N/A
Completed	`NCT00044473` - 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	Phase 3