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

Infectious Mononucleosis Clinical Trial

Official title:

Mikrobiologi Ved svær Akut Tonsillit, peritonsillær Phlegmone og infektiøs Mononukleose

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02715037
• Other study ID #: 52683
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2016
• Last updated: March 21, 2016
• Start date: June 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2016
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 2021
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Tonsillitis
• Cellulitis
• Communicable Diseases
• Infection
• Infectious Mononucleosis
• Peritonsillar Cellulitis
• Tonsillitis

Intervention

Other:
• Throat swabbing

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Tejs Ehlers Klug	Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Fusobacterium necrophorum in throat swab cultures		At acute consultation (day 0)	No
Secondary	Number of participants with recurrent throat infections (questionnaire)		Six months after acute consultation	No
Secondary	Number of participants without eradication of throat pathogens (throat cultures)	"Throat pathogens": Fusobacterium necrophorum, Beta-hemolytical streptococci, A. hemolyticum	14-28 days after acute consultation	No
Secondary	Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis	"Complications": admission, abscess Development, change of antibiotic treatment	14-28 days after acute consultation	No
Secondary	Prevalence of anti-Fusobacterium necrophorum antibody Development (two-fold or higher increase in antibody level) (blood samples)	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)	No