Clinical Trial: Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

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 Summary:

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.

Sponsor: Aarhus University Hospital

Current Primary Outcome: Procalcitonin [ Time Frame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after 3-4 month (average) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Centor score [ Time Frame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation ]

Original Secondary Outcome: Same as current

Information By: Aarhus University Hospital

Dates:
Date Received: July 31, 2012
Date Started: August 2012
Date Completion: March 2013
Last Updated: January 17, 2013
Last Verified: January 2013