Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

January 17, 2013 updated by: Ann Christensen, Aarhus University Hospital

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.

Study Overview

Status

Unknown

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ann MG Christensen, medical student
  • Phone Number: +45 28740001
  • Email: ann.mgc@hotmail.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The participants will bee examined in family practice in 30 minuts, measurement results will be available after 3-4 month (average)

Secondary Outcome Measures

Outcome Measure
Time Frame
Centor score
Time Frame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation
The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Tonsillar surface swabs obtained at time of consultation. The consultation takes about 30 minuts and results will be analyzed approx. 1 time per week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Tejs E Klug, MD, Aarhus University Hospital
  • Study Director: Therese Ovesen, DMSc, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (Estimate)

August 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Streptococcal Acute Tonsillitis

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