Clinical trial NCT01657968: Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis
Official title: Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Streptococcal Acute Tonsillitis
Keywords: Acute tonsillitis
Procalcitonin
Streptococcal antigen test
Centor Criteria
Infection marker
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Skodstrup Medical Clinic, Denmark
First posted: 2012-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute tonsillitis aged 15 to 40 years consulting their general practitioner with signs and symptoms of acute tonsillitis meeting to or more of Centors criteria.

Healthy control patients aged 15 to 40 years consulting their general practitioner in other reason than infection.

Brief summary: The primary purpose of the present study is to investigate the usefulness of Procalcitonin as a supplement to the Streptococcal antigen test and Centor criteria in the differential diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.

Furthermore, the investigators aim to examine Procalcitonin as a diagnostic marker in acute tonsillitis due to Fusobacterium Necrophorum.

Detailed description: Acute tonsillitis is based on typical symptoms (sore throat, pain on swallowing, and fever) and clinical findings of tonsillar exudate and hyperemia.

10-20% of patients seen by their family physician, have acute tonsillitis due to streptococci group A. In Denmark, Centors criteria and the Streptococcal antigen test (Strep. A-test) are gold standard in the diagnostic process of streptococcal acute tonsillitis. Although the sensitivity and specificity of the Strep. A-test is biochemically high, its clinical reliability is reduced due to several influential factors. Moreover, studies suggest that 4-10% of patients are tested false-negative based on clinical criteria and the Strep A-test.

Fusobacterium necrophorum are suspected to be the cause of acute tonsillitis in teenagers and young adults (5-15%). However, there is no rapid test available for this bacterium. Since tonsillar surface swab is not included in the diagnostic standard, family physicians get no information about infection due to Fusobacterium necrophorum or other pathogens.

C-reactive protein, leukocyte count and absolute neutrophil count as diagnostic markers are examined with variable results. Procalcitonin is a relatively new marker of bacterial infection, which has the advantage of more rapid and specific induction compared to the other markers.

Eligibility criteria: Patients with acute tonsillitis:

Inclusion Criteria:

* Age between 15 and 40 years.
* Subjective and objective signs of Acute Tonsillitis + presents of 2-4 Centor Criteria.
* participation accept after verbal and written information.

Exclusion Criteria:

* Antibiotic treatment within the last month.
* Other infection within the last month.
* Inadequate tonsil swabs due to lack of cooperation.
* Suspicion of peritonsillar abscess

Control patients:

Inclusion criteria:

* Age between 15 and 40 years.
* Participation accept after verbal and written information.

Exclusion Criteria:

* Antibiotic treatment within the last month.
* Infection within the last month.
* Tonsillectomy
* More than 2 cases of acute tonsillitis within the last 12 months.

Primary outcomes:
measure: Procalcitonin
timeFrame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after 3-4 month (average)
Secondary outcomes:
measure: Centor score
timeFrame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation
Other outcomes:
measure: Cultured bacteria
timeFrame: Tonsillar surface swabs obtained at time of consultation. The consultation takes about 30 minuts and results will be analyzed approx. 1 time per week.
Locations:
city: Skodstrup
country: Denmark
facility: Skoedstrup Medical Clinics
Study officials:
affiliation: Aarhus University Hospital
name: Tejs E Klug, MD
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital
name: Therese Ovesen, DMSc
role: STUDY_DIRECTOR
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