Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
1 other identifier
interventional
84
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 1999
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 18, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 20, 2012
June 1, 2012
12.8 years
November 18, 2010
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Within 60 days
Secondary Outcomes (1)
Time (days) to disappearance of pain
Within 60 days
Study Arms (2)
Amoxicillin-clavulanate
EXPERIMENTALOral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days
Placebo
PLACEBO COMPARATORInterventions
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Eligibility Criteria
You may qualify if:
- Children with acute otitis media
You may not qualify if:
- Amoxicillin allergy
- Tympanic membrane perforation
- Tympanostomy tubes (current)
- Complication of acute otitis media such as mastoiditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Pediatrics, Oulu University Hospital
Oulu, 90014, Finland
Lääkärikeskus Mehiläinen
Oulu, 90100, Finland
Related Publications (1)
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.
PMID: 24797294DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Matti Uhari, Professor
University of Oulu
- PRINCIPAL INVESTIGATOR
Terhi Tapiainen, MD, PhD
University of Oulu
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.
Study Record Dates
First Submitted
November 18, 2010
First Posted
November 19, 2010
Study Start
September 1, 1999
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 20, 2012
Record last verified: 2012-06