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

Sponsor

Tejs Ehlers Klug (Other)

Overall Status

Unknown status

CT.gov ID

NCT02715037

Collaborator

Statens Serum Institut (Other)

350

Enrollment

Location

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Anticipated 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 :

Jun 1, 2016

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	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 Names: 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 Names: 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 Names: 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 Names: Blood sample

Outcome Measures

Primary Outcome Measures

Prevalence of Fusobacterium necrophorum in throat swab cultures [At acute consultation (day 0)]

Secondary Outcome Measures

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.