Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- University of Turku
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 35 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
Intervention: amoxicillin-clavulanate (Drug)
2
Reconstituted placebo in 2 divided doses for 7 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
- 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)