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
About this trial
This is an interventional treatment trial for Otitis Media, Suppurative focused on measuring middle ear effusion, amoxicillin-clavulanate, tympanometry
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
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
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
Learn more about this trial
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
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