Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

This study is currently recruiting participants.
Verified January 2013 by Aarhus University Hospital
Sponsor:
Collaborator:
Skodstrup Medical Clinic, Denmark
Information provided by (Responsible Party):
Ann Christensen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01657968
First received: July 31, 2012
Last updated: January 17, 2013
Last verified: January 2013

July 31, 2012
January 17, 2013
August 2012
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01657968 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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.
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 ]
 
Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis
Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.
Probability Sample

Patients with acute tonsillitis aged 15 to 40 years consulting their general practitioner with signs and symptoms of acute tonsillitis meeting to or more of Centors criteria.

Healthy control patients aged 15 to 40 years consulting their general practitioner in other reason than infection.

Streptococcal Acute Tonsillitis
Not Provided
  • Acute tonsillitis
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
15 Years to 40 Years
No
Contact: Ann MG Christensen, medical student +45 28740001 ann.mgc@hotmail.com
Contact: Tejs E Klug, MD +45 51604046 tejsehlersklug@hotmail.com
Denmark
 
NCT01657968
1-10-72-321-12, 2007-58-0010
Yes
Ann Christensen, Aarhus University Hospital
Aarhus University Hospital
Skodstrup Medical Clinic, Denmark
Study Director: Tejs E Klug, MD Aarhus University Hospital
Study Director: Therese Ovesen, DMSc Aarhus University Hospital
Aarhus University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP