Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis
Recruitment status was: Recruiting
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.
Streptococcal Acute Tonsillitis
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis|
- Procalcitonin [ Time Frame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after 3-4 month (average) ] [ Designated as safety issue: No ]Procalcitonin from all 100 participants will be analyzed at once.
- Centor score [ Time Frame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation ] [ Designated as safety issue: No ]
- Cultured bacteria [ Time Frame: Tonsillar surface swabs obtained at time of consultation. The consultation takes about 30 minuts and results will be analyzed approx. 1 time per week. ] [ Designated as safety issue: No ]In both the acute tonsillitis group and the healthy control group.
Biospecimen Retention: Samples With DNA
Patients with acute tonsillitis:
- Oral temperature, streptococcal rapid antigen detection test, Tonsil surface swab for microbiological culture and a blood sample (measuring the infection markers: Procalcitonin, C-reactive protein, White blood cell count and Absolute neutrophile count).
Healthy control patients:
- Tonsil surface swab for microbiological culture.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Patients with acute tonsillitis aged 15 to 40 years meeting at least two of Centors criteria.
Healthy control patients
Control patients aged 15 to 40 years.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657968
|Skoedstrup Medical Clinics|
|Skodstrup, Denmark, 8541|
|Study Director:||Tejs E Klug, MD||Aarhus University Hospital|
|Study Director:||Therese Ovesen, DMSc||Aarhus University Hospital|