Completed

Adjuvant Therapy for Improved Acute Otitis Media Outcomes in Infants

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Antihistamine

+ Corticosteroid

Drug
Who is being recruted

Ear Diseases+1

+ Otitis

+ Otorhinolaryngologic Diseases

From 2 Months to 1 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner

Acute otitis media, a common childhood disease, often leads to hearing loss in children. Despite the existence of effective antibiotics, treatment failures, persistent fluid buildup, and recurrences are common. This study focuses on infants under one year old, aiming to improve their acute and long-term outcomes. The research explores if adding adjuvant therapy, either an antihistamine or a corticosteroid, to antibiotic treatment can enhance recovery. This could potentially address current challenges in treatment, providing a more effective solution for this condition. During this Phase III study, participants receive both antibiotic therapy and either an antihistamine or a corticosteroid. The study lasts for one year after enrollment. The impact of this combined treatment approach is evaluated to determine if it reduces treatment failures, persistent fluid buildup, and recurrences. By testing this new approach, the study hopes to find a more reliable treatment for acute otitis media in infants.

NCT00000363
Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 Months to 1 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesOtitisOtorhinolaryngologic DiseasesOtitis Media

Criteria

2 inclusion criteria required to participate
Have had two documented prior episodes of acute otitis media

Have no current middle ear effusion (fluid)

2 exclusion criteria prevent from participating
Have acute otitis media in addition to chronic otitis media

Have chronic otitis media

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Univ of Texas Med Branch Children's Hosp

Galveston, United StatesOpen Univ of Texas Med Branch Children's Hosp in Google Maps
CompletedOne Study Center