Microbiology of Severe Acute Tonsillitis, Peritonsillar Cellulitis, and Infectious Mononucleosis

March 21, 2016 updated by: Tejs Ehlers Klug

Mikrobiologi Ved svær Akut Tonsillit, peritonsillær Phlegmone og infektiøs Mononukleose

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 patients with severe acute tonsillitis 100 patients with peritonsillar cellulitis 50 patients with infectious mononucleosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Abscess formation.
  2. Previous tonsillectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute tonsillitis
Patients referred to the tertiary care center with severe acute tonsillitis but without peritonsillar cellulitis, infectious mononucleosis, or abscess formation.
Other: Throat swabbing
Other Names:
  • Blood sample
Peritonsillar cellulitis
Patients referred to the tertiary care center with severe acute tonsillitis and peritonsillar cellulitis but without abscess formation.
Other: Throat swabbing
Other Names:
  • Blood sample
Infectious mononucleosis
Patients referred to the tertiary care center with acute tonsillitis and biochemical or serological signs of infectious mononucleosis but without abscess formation.
Other: Throat swabbing
Other Names:
  • Blood sample
Controls
Patients treated for conditions not related to the throat and without signs or symptoms of recent throat disease.
Other: Throat swabbing
Other Names:
  • Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Fusobacterium necrophorum in throat swab cultures
Time Frame: At acute consultation (day 0)
At acute consultation (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with recurrent throat infections (questionnaire)
Time Frame: Six months after acute consultation
Six months after acute consultation
Number of participants without eradication of throat pathogens (throat cultures)
Time Frame: 14-28 days after acute consultation
"Throat pathogens": Fusobacterium necrophorum, Beta-hemolytical streptococci, A. hemolyticum
14-28 days after acute consultation
Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis
Time Frame: 14-28 days after acute consultation
"Complications": admission, abscess Development, change of antibiotic treatment
14-28 days after acute consultation
Prevalence of anti-Fusobacterium necrophorum antibody Development (two-fold or higher increase in antibody level) (blood samples)
Time Frame: In acute and convalescent sera (day 0 and 14-28)
Comparison of the prevalence of antibody Development (two-fold or higher increase in antibody level) between patients with recovery of Fusobacterium necrophorum in throat swabs versus patients without recovery of Fusobacterium necrophorum in throat swabs
In acute and convalescent sera (day 0 and 14-28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tejs Ehlers Klug

Collaborators

Statens Serum Institut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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