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

Primary Purpose

Otitis Media, Suppurative

Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Amoxicillin-clavulanate
Placebo
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media, Suppurative focused on measuring middle ear effusion, amoxicillin-clavulanate, tympanometry

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Department of Pediatrics, Oulu University Hospital
  • Lääkärikeskus Mehiläinen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amoxicillin-clavulanate

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time (days) to disappearance of pain

Full Information

First Posted
November 18, 2010
Last Updated
June 19, 2012
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT01244581
Brief Title
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
Official Title
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media, Suppurative
Keywords
middle ear effusion, amoxicillin-clavulanate, tympanometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin-clavulanate
Arm Type
Experimental
Arm Description
Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxicillin-clavulanate
Other Intervention Name(s)
Clavurion
Intervention Description
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo mixture in two daily doses for 7 days
Primary Outcome Measure Information:
Title
Time (days) to disappearance of middle ear effusion
Description
Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.
Time Frame
Within 60 days
Secondary Outcome Measure Information:
Title
Time (days) to disappearance of pain
Time Frame
Within 60 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti Uhari, Professor
Organizational Affiliation
University of Oulu
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90014
Country
Finland
Facility Name
Lääkärikeskus Mehiläinen
City
Oulu
ZIP/Postal Code
90100
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24797294
Citation
Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, Pokka T, Alho OP, Uhari M. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr. 2014 Jul;168(7):635-41. doi: 10.1001/jamapediatrics.2013.5311.
Results Reference
derived

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

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