Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

• Conditions: Streptococcal Acute Tonsillitis

• Registration Number: NCT01657968
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study First Submitted: 2012-07-31
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procalcitonin	The participants will bee examined in family practice in 30 minuts, measurement results will be available after 3-4 month (average)	Procalcitonin from all 100 participants will be analyzed at once.

Secondary Outcome Measures

Name	Time	Method
Centor score	The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation

Trial Locations

Locations (1)

Skoedstrup Medical Clinics; 🇩🇰 Skodstrup, Denmark