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

NCT02715037 | Unknown

• 1 other identifier: 52683
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Tonsillitis; Peritonsillar Cellulitis; Infectious Mononucleosis

Keywords

fusobacterium necrophorum; acute tonsillitis; peritonsillar cellulitis; infectious mononucleosis; microbiology; antibody development

Outcome Measures

Primary Outcomes (1)

• Prevalence of Fusobacterium necrophorum in throat swab cultures

  At acute consultation (day 0)

Secondary Outcomes (4)

• 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

• Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis

  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)

Study Arms (4)

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

Peritonsillar cellulitis

Patients referred to the tertiary care center with severe acute tonsillitis and peritonsillar cellulitis but without abscess formation.

Other: Throat swabbing

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

Controls

Patients treated for conditions not related to the throat and without signs or symptoms of recent throat disease.

Other: Throat swabbing

Interventions

Throat swabbing OTHER

Also known as: Blood sample

Acute tonsillitis; Controls; Infectious mononucleosis; Peritonsillar cellulitis

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Abscess formation.
• Previous tonsillectomy.

Sponsors & Collaborators

• Tejs Ehlers Klug: lead
• Statens Serum Institut: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (4)

• Klug TE, Henriksen JJ, Rusan M, Fuursted K, Krogfelt KA, Ovesen T, Struve C. Antibody development to Fusobacterium necrophorum in patients with peritonsillar abscess. Eur J Clin Microbiol Infect Dis. 2014 Oct;33(10):1733-9. doi: 10.1007/s10096-014-2130-y. Epub 2014 May 9.

  PMID: 24810966 BACKGROUND

• Klug TE. Incidence and microbiology of peritonsillar abscess: the influence of season, age, and gender. Eur J Clin Microbiol Infect Dis. 2014 Jul;33(7):1163-7. doi: 10.1007/s10096-014-2052-8. Epub 2014 Jan 29.

  PMID: 24474247 BACKGROUND

• Klug TE, Henriksen JJ, Fuursted K, Ovesen T. Significant pathogens in peritonsillar abscesses. Eur J Clin Microbiol Infect Dis. 2011 May;30(5):619-27. doi: 10.1007/s10096-010-1130-9. Epub 2010 Dec 22.

  PMID: 21181222 BACKGROUND

• Ehlers Klug T, Rusan M, Fuursted K, Ovesen T. Fusobacterium necrophorum: most prevalent pathogen in peritonsillar abscess in Denmark. Clin Infect Dis. 2009 Nov 15;49(10):1467-72. doi: 10.1086/644616.

  PMID: 19842975 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Throat swabs Blood samples

MeSH Terms

Conditions

Infectious Mononucleosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, associate professor

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 22, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2021
• Last Updated: March 22, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)