Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry

Phase 3

Completed

• Conditions: Otitis Media, Suppurative
• Interventions: Drug: Amoxicillin-clavulanate; Drug: Placebo

• Registration Number: NCT01244581
• Lead Sponsor: University of Oulu

Brief Summary

The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Children with acute otitis media

Exclusion Criteria

• Amoxicillin allergy
• Tympanic membrane perforation
• Tympanostomy tubes (current)
• Complication of acute otitis media such as mastoiditis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Amoxicillin-clavulanate	Amoxicillin-clavulanate	Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days
Placebo	Amoxicillin-clavulanate	-

Primary Outcome Measures

Name	Time	Method
Time (days) to disappearance of middle ear effusion	Within 60 days	Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.

Secondary Outcome Measures

Name	Time	Method
Time (days) to disappearance of pain	Within 60 days

Trial Locations

Locations (2)

Department of Pediatrics, Oulu University Hospital; 🇫🇮 Oulu, Finland

Lääkärikeskus Mehiläinen; 🇫🇮 Oulu, Finland