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Clinical Trials/NCT02715037
NCT02715037UnknownNot Applicable

Mikrobiologi Ved svær Akut Tonsillit, peritonsillær Phlegmone og infektiøs Mononukleose

Tejs Ehlers Klug1 site in 1 country350 target enrollmentStarted: June 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
350
Locations
1
Primary Endpoint
Prevalence of Fusobacterium necrophorum in throat swab cultures

Study Overview

Brief Summary

Prospective, observational study of the microbiology of patients referred to a tertiary care center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.

Detailed Description

Patients referred to tertiary care centers with acute throat infections are most often treated with antibiotics. However, very little is know concerning the prevalent pathogens in patients with acute throat infections without abscess formation. Evidence suggests that Fusobacterium necrophorum plays an important role in complications of acute tonsillitis (e.g. peritonsillar abscess), but also uncomplicated acute tonsillitis.

This study aims to explore the throat microbiology of patients with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis with a special attention to a possible role of Fusobacterium necrophorum.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients referred to our tertiary care center with acute tonsillitis with or without signs of peritonsillar cellulitis and with or without infectious mononucleosis.
  • Center Score 3 or 4.

Exclusion Criteria

  • Abscess formation.
  • Previous tonsillectomy.

Outcomes

Primary Outcomes

Prevalence of Fusobacterium necrophorum in throat swab cultures

Time Frame: At acute consultation (day 0)

Secondary Outcomes

  • Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis(14-28 days after acute consultation)
  • Number of participants with recurrent throat infections (questionnaire)(Six months after acute consultation)
  • Number of participants without eradication of throat pathogens (throat cultures)(14-28 days after acute consultation)
  • Prevalence of anti-Fusobacterium necrophorum antibody Development (two-fold or higher increase in antibody level) (blood samples)(In acute and convalescent sera (day 0 and 14-28))

Investigators

Sponsor
Tejs Ehlers Klug
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Tejs Ehlers Klug

Consultant, associate professor

Aarhus University Hospital

Study Sites (1)

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