Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children

NCT02935374 | Completed Phase 4

• 1 other identifier: OY20167
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they will be monitored as a separate group. The main outcomes of this trial are the changes in the intestinal microbiome after the treatment.

Conditions

Acute Otitis Media

Keywords

children; intestinal microbiome; microbiota; antimicrobial course; amoxicillin; amoxicillin-clavulanate; macrolide

Outcome Measures

Primary Outcomes (1)

• Change in the relative abundance of Firmicutes in stool samples

  Change in the relative abundance of Firmicutes in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

  Change from baseline to 10 days

Secondary Outcomes (14)

• Principal coordinate analysis (PCA) of fecal samples

  10 days

• Change in the relative abundance of Actinobacteria in stool samples

  Change from baseline to 10 days

• Change in the relative abundance of Bacteroidetes in stool samples

  Change from baseline to 10 days

• Change in the relative abundance of Proteobacteria in stool samples

  Change from baseline to 10 days

• Change in the relative abundance of Verrucomicrobia in stool samples

  Change from baseline to 10 days

Study Arms (4)

Amoxicillin

ACTIVE COMPARATOR

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.

Drug: Amoxicillin

Amoxicillin-Potassium Clavulanate

ACTIVE COMPARATOR

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.

Drug: Amoxicillin-Potassium Clavulanate

Wait and see

NO INTERVENTION

The children with acute otitis media will be monitored without antimicrobial treatment.

Macrolide

OTHER

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.

Drug: Macrolide

Interventions

Amoxicillin DRUG

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

Amoxicillin-Potassium Clavulanate DRUG

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.

Amoxicillin-Potassium Clavulanate

Macrolide DRUG

The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately

Macrolide

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• acute symptoms of respiratory infection AND
• signs of inflammation on the tympanic membrane in otoscopy AND
• middle ear effusion found in pneumatic otoscopy

You may not qualify if:

• Suspected or proven complication of acute otitis media (for example acute mastoiditis or perforated tympanic membrane)
• 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

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

Mehiläinen, private practice

Oulu, Finland

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Macrolides

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; Drug Combinations; Pharmaceutical Preparations; Lactones; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 17, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)