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Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01657968
Enrollment
200
Registered
2012-08-06
Start date
2012-08-31
Completion date
2013-03-31
Last updated
2013-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Streptococcal Acute Tonsillitis

Keywords

Acute tonsillitis, Procalcitonin, Streptococcal antigen test, Centor Criteria, Infection marker

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.

Interventions

None listed

Sponsors

Skodstrup Medical Clinic, Denmark
CollaboratorUNKNOWN
Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
ProcalcitoninThe 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

MeasureTime frame
Centor scoreThe participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation

Other

MeasureTime frameDescription
Cultured bacteriaTonsillar 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.

Countries

Denmark

Contacts

Primary ContactAnn MG Christensen, medical student
ann.mgc@hotmail.com+45 28740001
Backup ContactTejs E Klug, MD
tejsehlersklug@hotmail.com+45 51604046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026