Overview

This trial is active, not recruiting.

Condition acute otitis media
Treatments amoxicillin-clavulanate, placebo
Phase phase 4
Sponsor University of Turku
Collaborator National Institute for Health and Welfare, Finland
Start date March 2006
End date December 2008
Trial size 320 participants
Trial identifier NCT00299455, RRR-60

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
amoxicillin-clavulanate
Amoxicillin clavulanate 40 mg/kg/day divided into two daily doses for 7 days. Capsules will be produced by pulverizing amoxicillin clavulanate tablets (Augmentin 875 mg; manufacturer Glaxo SmithKline Beecham; ATC Code: J01CR02) and mixing that with lactose monohydrate. Each capsule will contain Augmentin tablet powder 68 mg and lactose monohydrate 572 mg. This means amoxicillin 40 mg and clavulanate 5,7 mg respecting the dose per 2 kg.
(Placebo Comparator)
Reconstituted placebo in 2 divided doses for 7 days.
placebo
Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Primary Outcomes

Measure
Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo
time frame: During the first 8 days of follow-up

Secondary Outcomes

Measure
Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo
time frame: Duration of study
Time to resolution of acute inflammatory signs of middle ear
time frame: 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
time frame: 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
time frame: First 7 days of follow-up
Compare the incidence of adverse events accompanying the 2 treatment regimens
time frame: Duration of study
Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1
time frame: Duration of study
Time to relapse of acute otitis media
time frame: Study days 9-17
Time to first reinfection of acute otitis media
time frame: From study day 18 to the end of follow-up

Eligibility Criteria

Male or female participants from 6 months up to 35 months old.

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

Additional Information

Official title Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children
Principal investigator Aino Ruohola, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Turku.