Amoxicillin Clavulanate in Treatment of Acute Otitis Media

Phase 4

• Conditions: Acute Otitis Media
• Interventions: Drug: amoxicillin-clavulanate; Drug: Placebo

• Registration Number: NCT00299455
• Lead Sponsor: University of Turku

Brief Summary

This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-03
• Study First Submitted QC: 2006-03-03
• Study First Posted: 2006-03-06
• Primary Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-10
• Last Update Posted: 2009-02-11
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Acute otitis media
• Age 6 - 35 mo

Exclusion Criteria

• Spontaneous perforation of the tympanic membrane and drainage
• Systemic or nasal corticosteroid therapy within 3 preceding days
• Antihistamine therapy with 3 preceding days
• Oseltamivir therapy within 3 preceding days
• Allergy to amoxicillin/penicillin
• Tympanostomy tube present in tympanic membrane
• Clinical evidence of infection requiring systemic antimicrobial treatment
• Documented Ebstein Barr virus infection within 7 preceding days
• Down syndrome or other condition to affect middle ear infections
• Known immunodeficiency
• Vomiting or another symptom to violate per oral dosage
• Poor parental co-operation due to language or other reasons
• Use of any investigational drugs during the 4 preceding weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	amoxicillin-clavulanate	Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
2	Placebo	Reconstituted placebo in 2 divided doses for 7 days.

Primary Outcome Measures

Name	Time	Method
Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo	During the first 8 days of follow-up

Secondary Outcome Measures

Name	Time	Method
Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo	Duration of study
Time to resolution of acute inflammatory signs of middle ear	Duration of study
Compare the 2 treatment groups regarding the doses of analgesic medication and number of days analgesics are administered by children's parents	First 7 days of follow-up
Compare the 2 treatment groups regarding the number of days with absenteeism from day care and/or parental absenteeism from work	First 7 days of follow-up
Compare the incidence of adverse events accompanying the 2 treatment regimens	Duration of study
Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1	Duration of study
Time to relapse of acute otitis media	Study days 9-17
Time to first reinfection of acute otitis media	From study day 18 to the end of follow-up

Trial Locations

Locations (1)

Department of Pediatrics, Turku University Hospital; 🇫🇮 Turku, Finland