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Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

A

Aarhus University Hospital

Status

Unknown

Conditions

Streptococcal Acute Tonsillitis

Study type

Observational

Funder types

Other

Identifiers

NCT01657968
2007-58-0010 (Other Identifier)
1-10-72-321-12

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

15 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

200 participants in 2 patient groups

Acute tonsillitis
Description:
Patients with acute tonsillitis aged 15 to 40 years meeting at least two of Centors criteria.
Healthy control patients
Description:
Control patients aged 15 to 40 years.

Trial contacts and locations

1

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Central trial contact

Ann MG Christensen, medical student; Tejs E Klug, MD

Data sourced from clinicaltrials.gov

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