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

• Conditions: Acute Tonsillitis; Infectious Mononucleosis; Peritonsillar Cellulitis
• Interventions: Other: Throat swabbing

• Registration Number: NCT02715037
• Lead Sponsor: Tejs Ehlers Klug

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.

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-21
• Last Update Submitted: 2016-03-21
• Study First Posted: 2016-03-22
• Last Update Posted: 2016-03-22
• Study Start: 2016-06
• Primary Completion: 2019-05
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prevalence of Fusobacterium necrophorum in throat swab cultures	At acute consultation (day 0)

Secondary Outcome Measures

Name	Time	Method
Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis	14-28 days after acute consultation	"Complications": admission, abscess Development, change of antibiotic treatment
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	"Throat pathogens": Fusobacterium necrophorum, Beta-hemolytical streptococci, A. hemolyticum
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)	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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark