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Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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
Streptococcal Acute Tonsillitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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.

Estimated Enrollment: 200
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)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657968

Contacts
Contact: Ann MG Christensen, medical student +45 28740001 ann.mgc@hotmail.com
Contact: Tejs E Klug, MD +45 51604046 tejsehlersklug@hotmail.com

Locations
Denmark
Skoedstrup Medical Clinics Recruiting
Skodstrup, Denmark, 8541
Contact: Ann MG Christensen, Stud.med.    +45 28740001    ann.mgc@hotmail.com   
Contact: Tejs E Klug, MD    +45 51604046    tejsehlersklug@hotmail.com   
Sponsors and Collaborators
Aarhus University Hospital
Skodstrup Medical Clinic, Denmark
Investigators
Study Director: Tejs E Klug, MD Aarhus University Hospital
Study Director: Therese Ovesen, DMSc Aarhus University Hospital
  More Information

Publications:

Responsible Party: Ann Christensen, Research year student, medical student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01657968     History of Changes
Other Study ID Numbers: 1-10-72-321-12, 2007-58-0010
Study First Received: July 31, 2012
Last Updated: January 17, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:
Acute tonsillitis
Procalcitonin
Streptococcal antigen test
Centor Criteria
Infection marker

Additional relevant MeSH terms:
Tonsillitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Pharyngitis
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 25, 2014