Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
NCT ID: NCT02935374
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
73 participants
INTERVENTIONAL
2016-11-30
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Amoxicillin
The children with acute otitis media will be treated with amoxicillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.
Amoxicillin
The children with acute otitis media will be treated with amoxixillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.
Amoxicillin-Potassium Clavulanate
The children with acute otitis media will be treated with amoxicillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.
Amoxicillin-Potassium Clavulanate
The children with acute otitis media will be treated with amoxixillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.
Wait and see
The children with acute otitis media will be monitored without antimicrobial treatment.
No interventions assigned to this group
Macrolide
The children with acute otitis media with known allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored as a separate group, outside randomization.
Macrolide
The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately
Interventions
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Amoxicillin
The children with acute otitis media will be treated with amoxixillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.
Amoxicillin-Potassium Clavulanate
The children with acute otitis media will be treated with amoxixillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.
Macrolide
The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately
Eligibility Criteria
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Inclusion Criteria
* signs of inflammation on the tympanic membrane in otoscopy AND
* middle ear effusion found in pneumatic otoscopy
Exclusion Criteria
* Severe acute otitis media: severe pain and fever \> 39 degrees C
* Bilateral acute otitis media in a child younger than 2 years
* Primary or secondary immunodeficiency or Downs syndrome
* Impaired general condition or suspected severe bacterial infection
* Allergy to both amoxicillin and macrolide
* Acute otorrhea through tympanostomy tube
* Antimicrobial treatment ongoing or during previous 7 days
6 Months
7 Years
ALL
No
Sponsors
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Oulu University Hospital
OTHER
University of Oulu
OTHER
Responsible Party
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Locations
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Mehiläinen, private practice
Oulu, , Finland
Countries
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Other Identifiers
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OY20167
Identifier Type: -
Identifier Source: org_study_id
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