Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis
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|ClinicalTrials.gov Identifier: NCT01657968|
Recruitment Status : Unknown
Verified January 2013 by Ann Christensen, Aarhus University Hospital.
Recruitment status was: Recruiting
First Posted : August 6, 2012
Last Update Posted : January 18, 2013
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.
|Condition or disease|
|Streptococcal Acute Tonsillitis|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
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.
- Procalcitonin [ Time Frame: 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.
- Centor score [ Time Frame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation ]
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657968
|Contact: Ann MG Christensen, medical student||+45 firstname.lastname@example.org|
|Contact: Tejs E Klug, MD||+45 email@example.com|
|Skoedstrup Medical Clinics||Recruiting|
|Skodstrup, Denmark, 8541|
|Contact: Ann MG Christensen, Stud.med. +45 28740001 firstname.lastname@example.org|
|Contact: Tejs E Klug, MD +45 51604046 email@example.com|
|Study Director:||Tejs E Klug, MD||Aarhus University Hospital|
|Study Director:||Therese Ovesen, DMSc||Aarhus University Hospital|