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

University of Oulu

Status and phase: Completed; Phase 3

Conditions: Otitis Media, Suppurative

Treatments: Drug: Placebo; Drug: Amoxicillin-clavulanate

Study type: Interventional

Funder types: Other

Identifiers

NCT01244581

OYS_Tapiainen_001

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Amoxicillin-clavulanate

Experimental group

Description:

Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days

Treatment:

Drug: Amoxicillin-clavulanate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Amoxicillin-clavulanate