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

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ClinicalTrials.gov Identifier: NCT02715037
Recruitment Status : Not yet recruiting
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
Statens Serum Institut
Information provided by (Responsible Party):
Tejs Ehlers Klug, Aarhus University Hospital

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.

Condition or disease Intervention/treatment
Acute Tonsillitis Peritonsillar Cellulitis Infectious Mononucleosis Other: Throat swabbing

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
Estimated Enrollment : 350 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mikrobiologi Ved svær Akut Tonsillit, peritonsillær Phlegmone og infektiøs Mononukleose
Study Start Date : June 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Blood sample




Primary Outcome Measures :
  1. Prevalence of Fusobacterium necrophorum in throat swab cultures [ Time Frame: At acute consultation (day 0) ]

Secondary Outcome Measures :
  1. Number of participants with recurrent throat infections (questionnaire) [ Time Frame: Six months after acute consultation ]
  2. 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

  3. 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

  4. 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


Biospecimen Retention:   Samples With DNA
Throat swabs Blood samples


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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 patients with severe acute tonsillitis 100 patients with peritonsillar cellulitis 50 patients with infectious mononucleosis
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715037


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Tejs Ehlers Klug
Statens Serum Institut

Publications:
Responsible Party: Tejs Ehlers Klug, Consultant, associate professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02715037     History of Changes
Other Study ID Numbers: 52683
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tejs Ehlers Klug, Aarhus University Hospital:
fusobacterium necrophorum
acute tonsillitis
peritonsillar cellulitis
infectious mononucleosis
microbiology
antibody development

Additional relevant MeSH terms:
Communicable Diseases
Infection
Cellulitis
Tonsillitis
Infectious Mononucleosis
Peritonsillar Abscess
Skin Diseases, Infectious
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Leukocyte Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abscess