Amoxicillin Clavulanate in Treatment of Acute Otitis Media

Acute Otitis Media Clinical Trial

Official title:

Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00299455
• Other study ID #: RRR-60
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 3, 2006
• Last updated: February 10, 2009
• Start date: March 2006
• Est. completion date: March 2009

Study information

• Verified date: February 2009
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Drug:
• 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
Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Locations

Country	Name	City	State
Finland	Department of Pediatrics, Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo		During the first 8 days of follow-up	No
Secondary	Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo		Duration of study	No
Secondary	Time to resolution of acute inflammatory signs of middle ear		Duration of study	No
Secondary	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	No
Secondary	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	No
Secondary	Compare the incidence of adverse events accompanying the 2 treatment regimens		Duration of study	Yes
Secondary	Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1		Duration of study	No
Secondary	Time to relapse of acute otitis media		Study days 9-17	No
Secondary	Time to first reinfection of acute otitis media		From study day 18 to the end of follow-up	No