NCT00299455

Amoxicillin Clavulanate in Treatment of Acute Otitis Media

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: University of Turku · Academic / Other
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Media

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2006-03-06
• Last updated: 2009-02-11

Locations

2 sites across 1 country: Finland