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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

History of Changes

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:

MedlinePlus related topics: Tonsils and Adenoids

U.S. FDA Resources

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

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:

Elsammak M, Hanna H, Ghazal A, Edeen FB, Kandil M. Diagnostic value of serum procalcitonin and C-reactive protein in Egyptian children with streptococcal tonsillopharyngitis. Pediatr Infect Dis J. 2006 Feb;25(2):174-6.

Ehlers Klug T, Rusan M, Fuursted K, Ovesen T. Fusobacterium necrophorum: most prevalent pathogen in peritonsillar abscess in Denmark. Clin Infect Dis. 2009 Nov 15;49(10):1467-72.

Stenfeldt K, Hermansson A. Acute mastoiditis in southern Sweden: a study of occurrence and clinical course of acute mastoiditis before and after introduction of new treatment recommendations for AOM. Eur Arch Otorhinolaryngol. 2010 Dec;267(12):1855-61. Epub 2010 Jul 8.

Ylikoski J, Karjalainen J. Acute tonsillitis in young men: etiological agents and their differentiation. Scand J Infect Dis. 1989;21(2):169-74.

Komaroff AL, Pass TM, Aronson MD, Ervin CT, Cretin S, Winickoff RN, Branch WT Jr. The prediction of streptococcal pharyngitis in adults. J Gen Intern Med. 1986 Jan-Feb;1(1):1-7.

McIsaac WJ, Goel V, To T, Low DE. The validity of a sore throat score in family practice. CMAJ. 2000 Oct 3;163(7):811-5.

Rimoin AW, Walker CL, Hamza HS, Elminawi N, Ghafar HA, Vince A, da Cunha AL, Qazi S, Gardovska D, Steinhoff MC. The utility of rapid antigen detection testing for the diagnosis of streptococcal pharyngitis in low-resource settings. Int J Infect Dis. 2010 Dec;14(12):e1048-53. Epub 2010 Oct 30.

Begovac J, Bobinac E, Benic B, Desnica B, Maretic T, Basnec A, Kuzmanovic N. Asymptomatic pharyngeal carriage of beta-haemolytic streptococci and streptococcal pharyngitis among patients at an urban hospital in Croatia. Eur J Epidemiol. 1993 Jul;9(4):405-10. Review.

Lindbaek M, Høiby EA, Lermark G, Steinsholt IM, Hjortdahl P. Which is the best method to trace group A streptococci in sore throat patients: culture or GAS antigen test? Scand J Prim Health Care. 2004 Dec;22(4):233-8.

Edmonson MB, Farwell KR. Relationship between the clinical likelihood of group a streptococcal pharyngitis and the sensitivity of a rapid antigen-detection test in a pediatric practice. Pediatrics. 2005 Feb;115(2):280-5.

Del Mar CB, Glasziou PP, Spinks AB. Antibiotics for sore throat. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD000023. Review.

Rusan M, Klug TE, Ovesen T. An overview of the microbiology of acute ear, nose and throat infections requiring hospitalisation. Eur J Clin Microbiol Infect Dis. 2009 Mar;28(3):243-51. Epub 2008 Oct 2.

Aliyu SH, Marriott RK, Curran MD, Parmar S, Bentley N, Brown NM, Brazier JS, Ludlam H. Real-time PCR investigation into the importance of Fusobacterium necrophorum as a cause of acute pharyngitis in general practice. J Med Microbiol. 2004 Oct;53(Pt 10):1029-35.

Jensen A, Hagelskjaer Kristensen L, Prag J. Detection of Fusobacterium necrophorum subsp. funduliforme in tonsillitis in young adults by real-time PCR. Clin Microbiol Infect. 2007 Jul;13(7):695-701. Epub 2007 Apr 2.

Centor RM. Expand the pharyngitis paradigm for adolescents and young adults. Ann Intern Med. 2009 Dec 1;151(11):812-5.

Veasy LG, Tani LY, Hill HR. Persistence of acute rheumatic fever in the intermountain area of the United States. J Pediatr. 1994 Jan;124(1):9-16. PubMed PMID: 7802743.

Gulich MS, Matschiner A, Glück R, Zeitler HP. Improving diagnostic accuracy of bacterial pharyngitis by near patient measurement of C-reactive protein (CRP). Br J Gen Pract. 1999 Feb;49(439):119-21.

Kaplan EL, Wannamaker LW. C-reactive protein in streptococcal pharyngitis. Pediatrics. 1977 Jul;60(1):28-32.

Putto A, Meurman O, Ruuskanen O. C-reactive protein in the differentiation of adenoviral, Epstein-Barr viral and streptococcal tonsillitis in children. Eur J Pediatr. 1986 Aug;145(3):204-6.

Centor RM, Witherspoon JM, Dalton HP, Brody CE, Link K. The diagnosis of strep throat in adults in the emergency room. Med Decis Making. 1981;1(3):239-46.

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
Peritonsillar Abscess
Abscess
Suppuration
Infection
Pharyngitis

Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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