Clinical trial NCT02715037: Microbiology of Severe Acute Tonsillitis, Peritonsillar Cellulitis, and Infectious Mononucleosis
Official title: Mikrobiologi Ved svær Akut Tonsillit, peritonsillær Phlegmone og infektiøs Mononukleose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Tonsillitis
Peritonsillar Cellulitis
Infectious Mononucleosis
Keywords: fusobacterium necrophorum
acute tonsillitis
peritonsillar cellulitis
infectious mononucleosis
microbiology
antibody development
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
First posted: 2016-03-22
Enrollment: 350
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients with severe acute tonsillitis 100 patients with peritonsillar cellulitis 50 patients with infectious mononucleosis

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.

Eligibility 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.

Primary outcomes:
measure: Prevalence of Fusobacterium necrophorum in throat swab cultures
timeFrame: At acute consultation (day 0)
Secondary outcomes:
measure: Number of participants with recurrent throat infections (questionnaire)
timeFrame: Six months after acute consultation
measure: Number of participants without eradication of throat pathogens (throat cultures)
timeFrame: 14-28 days after acute consultation
measure: Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis
timeFrame: 14-28 days after acute consultation
measure: Prevalence of anti-Fusobacterium necrophorum antibody Development (two-fold or higher increase in antibody level) (blood samples)
timeFrame: In acute and convalescent sera (day 0 and 14-28)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.