Status:
UNKNOWN
Amoxicillin Clavulanate in Treatment of Acute Otitis Media
Lead Sponsor:
University of Turku
Collaborating Sponsors:
Finnish Institute for Health and Welfare
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-35 years
Phase:
PHASE4
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 allo...
Eligibility Criteria
Inclusion
- Acute otitis media
- Age 6 - 35 mo
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00299455
Start Date
March 1 2006
End Date
March 1 2009
Last Update
February 11 2009
Active Locations (2)
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1
Department of Pediatrics, Turku University Hospital
Turku, Finland, 20521
2
Turku, Finland