Streptococcal Acute TonsillitisNCT01657968
Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis
An observational study of Streptococcal Acute Tonsillitis, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Streptococcal Acute Tonsillitis
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
- Age between 15 and 40 years.
- Participation accept after verbal and written information.
Who cannot join
- 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:
- Antibiotic treatment within the last month.
Show all 9Show fewer
- Infection within the last month.
- Tonsillectomy
- More than 2 cases of acute tonsillitis within the last 12 months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Skoedstrup Medical Clinics
Skødstrup, 8541
Ann MG Christensen, Stud.med., +45 28740001, ann.mgc@hotmail.com
Tejs E Klug, MD, +45 51604046, tejsehlersklug@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Streptococcal Acute Tonsillitis
- Keywords
- Acute tonsillitis, Procalcitonin, Streptococcal antigen test, Centor Criteria, Infection marker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Procalcitonin
Procalcitonin from all 100 participants will be analyzed at once.
Measured: The participants will bee examined in family practice in 30 minuts, measurement results will be available after 3-4 month (average)
Secondary outcomes (1)
Centor score
Measured: The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Streptococcal Acute TonsillitisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Skodstrup Medical Clinic, Denmark
- Responsible party
- Principal investigator, Ann Christensen, Aarhus University Hospital
- Investigators
- Tejs E Klug, MD, Study director, Aarhus University HospitalTherese Ovesen, DMSc, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657968
- Sponsor's protocol ID
- 1-10-72-321-12
- Other IDs
- 2007-58-0010
- Status last verified
- Jan 2013
- First submitted
- 31 Jul 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1097/01.inf.0000199273.37314.b2.
PubMed 16462299Ehlers 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. doi: 10.1086/644616.
PubMed 19842975Diamantis PK, George S, Alexander DK, Georgios MF, Constantinos AB, Sofia M, John AP, George AV. C-Reactive Protein and serum Procalcitonin Levels as Markers of Bacterial Upper Respiratory Tract Infections. American Journal if Infectious Diseases 5(4): 282-287, 2009.
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. doi: 10.1007/s00405-010-1325-9. Epub 2010 Jul 8.
PubMed 20614127Ylikoski J, Karjalainen J. Acute tonsillitis in young men: etiological agents and their differentiation. Scand J Infect Dis. 1989;21(2):169-74. doi: 10.3109/00365548909039965.
PubMed 2543062Komaroff 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. doi: 10.1007/BF02596317.
PubMed 3534166McIsaac 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.
PubMed 11033707Rimoin 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. doi: 10.1016/j.ijid.2010.02.2269. Epub 2010 Oct 30.
PubMed 21036645Begovac 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. doi: 10.1007/BF00157398.
PubMed 8243596Lindbaek M, Hoiby 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. doi: 10.1080/02813430410006675.
PubMed 15765639Edmonson 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. doi: 10.1542/peds.2004-0907.
PubMed 15687433Del Mar CB, Glasziou PP, Spinks AB. Antibiotics for sore throat. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD000023. doi: 10.1002/14651858.CD000023.pub3.
PubMed 17054126Rusan 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. doi: 10.1007/s10096-008-0619-y. Epub 2008 Oct 2.
PubMed 18830726Aliyu 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):1029-1035. doi: 10.1099/jmm.0.45648-0.
PubMed 15358827Jensen 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. doi: 10.1111/j.1469-0691.2007.01719.x. Epub 2007 Apr 2.
PubMed 17403128
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis
- ClinicalTrials.gov ID
- NCT01657968
- Acronym / sponsor ID
- 1-10-72-321-12
- Conditions
- Streptococcal Acute Tonsillitis
- Keywords
- Acute tonsillitis, Procalcitonin, Streptococcal antigen test, Centor Criteria, Infection marker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Skodstrup Medical Clinic, Denmark
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- Age between 15 and 40 years.
- Participation accept after verbal and written information.
Key exclusion criteria (9 listed)
- Antibiotic treatment within the last month.
- Other infection within the last month.
- Inadequate tonsil swabs due to lack of cooperation.
- Suspicion of peritonsillar abscess
- Antibiotic treatment within the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Centor score
Time frame: The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Results publication: PubMed 16462299Elsammak 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. doi: 10.1097/01.inf.0000199273.37314.b2.
- Results publication: PubMed 19842975Ehlers 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. doi: 10.1086/644616.
- Results publicationDiamantis PK, George S, Alexander DK, Georgios MF, Constantinos AB, Sofia M, John AP, George AV. C-Reactive Protein and serum Procalcitonin Levels as Markers of Bacterial Upper Respiratory Tract Infections. American Journal if Infectious Diseases 5(4): 282-287, 2009.
- Results publication: PubMed 20614127Stenfeldt 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. doi: 10.1007/s00405-010-1325-9. Epub 2010 Jul 8.
- Results publication: PubMed 2543062Ylikoski J, Karjalainen J. Acute tonsillitis in young men: etiological agents and their differentiation. Scand J Infect Dis. 1989;21(2):169-74. doi: 10.3109/00365548909039965.
- Results publication: PubMed 3534166Komaroff 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. doi: 10.1007/BF02596317.
- Results publication: PubMed 11033707McIsaac 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.
- Results publication: PubMed 21036645Rimoin 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. doi: 10.1016/j.ijid.2010.02.2269. Epub 2010 Oct 30.
- Results publication: PubMed 8243596Begovac 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. doi: 10.1007/BF00157398.
- Results publication: PubMed 15765639Lindbaek M, Hoiby 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. doi: 10.1080/02813430410006675.
- Results publication: PubMed 15687433Edmonson 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. doi: 10.1542/peds.2004-0907.
- Results publication: PubMed 17054126Del Mar CB, Glasziou PP, Spinks AB. Antibiotics for sore throat. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD000023. doi: 10.1002/14651858.CD000023.pub3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejs E Klug, MD study director
Aarhus University Hospital
Therese Ovesen, DMSc study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Acute Tonsillitis, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann MG Christensen, medical student (+45 28740001, ann.mgc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01657968, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.