Acute TonsillitisNCT02715037
Microbiology of Severe Acute Tonsillitis, Peritonsillar Cellulitis, and Infectious Mononucleosis
An observational study of Acute Tonsillitis and Peritonsillar Cellulitis, run by Tejs Ehlers Klug at 1 site in Denmark.
Trial summary
Prospective, observational study of the microbiology of patients referred to a tertiary care center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Tonsillitis, Peritonsillar Cellulitis, Infectious Mononucleosis
- What is being tested?
- Throat swabbing
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Dec 2021
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: 100 patients with severe acute tonsillitis 100 patients with peritonsillar cellulitis 50 patients with infectious mononucleosis
Who may be able to join
- Patients referred to our tertiary care center with acute tonsillitis with or without signs of peritonsillar cellulitis and with or without infectious mononucleosis.
- Center Score 3 or 4.
Who cannot join
- Abscess formation.
- Previous tonsillectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mikrobiologi Ved svær Akut Tonsillit, peritonsillær Phlegmone og infektiøs Mononukleose
Prospective, observational study of the microbiology of patients referred to a tertiary care center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.
Read the detailed description
Patients referred to tertiary care centers with acute throat infections are most often treated with antibiotics. However, very little is know concerning the prevalent pathogens in patients with acute throat infections without abscess formation. Evidence suggests that Fusobacterium necrophorum plays an important role in complications of acute tonsillitis (e.g. peritonsillar abscess), but also uncomplicated acute tonsillitis.
This study aims to explore the throat microbiology of patients with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis with a special attention to a possible role of Fusobacterium necrophorum.
- Being tested
- Throat swabbing
- Keywords
- fusobacterium necrophorum, acute tonsillitis, peritonsillar cellulitis, infectious mononucleosis, microbiology, antibody development
- Medical subject headings
- Infectious Mononucleosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Throat swabbingOther
Also called Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Acute tonsillitis | Patients referred to the tertiary care center with severe acute tonsillitis but without peritonsillar cellulitis, infectious mononucleosis, or abscess formation. Receives: Other: Throat swabbing | |
| Peritonsillar cellulitis | Patients referred to the tertiary care center with severe acute tonsillitis and peritonsillar cellulitis but without abscess formation. Receives: Other: Throat swabbing | |
| Infectious mononucleosis | Patients referred to the tertiary care center with acute tonsillitis and biochemical or serological signs of infectious mononucleosis but without abscess formation. Receives: Other: Throat swabbing | |
| Controls | Patients treated for conditions not related to the throat and without signs or symptoms of recent throat disease. Receives: Other: Throat swabbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Fusobacterium necrophorum in throat swab cultures
Measured: At acute consultation (day 0)
Secondary outcomes (4)
Number of participants with recurrent throat infections (questionnaire)
Measured: Six months after acute consultation
Number of participants without eradication of throat pathogens (throat cultures)
"Throat pathogens": Fusobacterium necrophorum, Beta-hemolytical streptococci, A. hemolyticum
Measured: 14-28 days after acute consultation
Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis
"Complications": admission, abscess Development, change of antibiotic treatment
Measured: 14-28 days after acute consultation
Prevalence of anti-Fusobacterium necrophorum antibody Development (two-fold or higher increase in antibody level) (blood samples)
Comparison of the prevalence of antibody Development (two-fold or higher increase in antibody level) between patients with recovery of Fusobacterium necrophorum in throat swabs versus patients without recovery of Fusobacterium necrophorum in throat swabs
Measured: In acute and convalescent sera (day 0 and 14-28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute TonsillitisStudies of the same condition, open and under way.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tejs Ehlers Klug
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Sponsor-investigator, Tejs Ehlers Klug, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715037
- Sponsor's protocol ID
- 52683
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klug TE, Henriksen JJ, Rusan M, Fuursted K, Krogfelt KA, Ovesen T, Struve C. Antibody development to Fusobacterium necrophorum in patients with peritonsillar abscess. Eur J Clin Microbiol Infect Dis. 2014 Oct;33(10):1733-9. doi: 10.1007/s10096-014-2130-y. Epub 2014 May 9.
PubMed 24810966Klug TE. Incidence and microbiology of peritonsillar abscess: the influence of season, age, and gender. Eur J Clin Microbiol Infect Dis. 2014 Jul;33(7):1163-7. doi: 10.1007/s10096-014-2052-8. Epub 2014 Jan 29.
PubMed 24474247Klug TE, Henriksen JJ, Fuursted K, Ovesen T. Significant pathogens in peritonsillar abscesses. Eur J Clin Microbiol Infect Dis. 2011 May;30(5):619-27. doi: 10.1007/s10096-010-1130-9. Epub 2010 Dec 22.
PubMed 21181222Ehlers 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 19842975
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mikrobiologi Ved svær Akut Tonsillit, peritonsillær Phlegmone og infektiøs Mononukleose
- ClinicalTrials.gov ID
- NCT02715037
- Acronym / sponsor ID
- 52683
- Keywords
- fusobacterium necrophorum, acute tonsillitis, peritonsillar cellulitis, infectious mononucleosis, microbiology, antibody development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tejs Ehlers KlugUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- Jun 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Mar 2016 (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.
Prospective, observational study of the microbiology of patients referred to a tertiary care center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.
Detailed description
Patients referred to tertiary care centers with acute throat infections are most often treated with antibiotics. However, very little is know concerning the prevalent pathogens in patients with acute throat infections without abscess formation. Evidence suggests that Fusobacterium necrophorum plays an important role in complications of acute tonsillitis (e.g. peritonsillar abscess), but also uncomplicated acute tonsillitis.
This study aims to explore the throat microbiology of patients with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis with a special attention to a possible role of Fusobacterium necrophorum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute tonsillitis | – | Other: Throat swabbingPatients referred to the tertiary care center with severe acute tonsillitis but without peritonsillar cellulitis, infectious mononucleosis, or abscess formation. |
| Peritonsillar cellulitis | – | Other: Throat swabbingPatients referred to the tertiary care center with severe acute tonsillitis and peritonsillar cellulitis but without abscess formation. |
| Infectious mononucleosis | – | Other: Throat swabbingPatients referred to the tertiary care center with acute tonsillitis and biochemical or serological signs of infectious mononucleosis but without abscess formation. |
| Controls | – | Other: Throat swabbingPatients treated for conditions not related to the throat and without signs or symptoms of recent throat disease. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 100 patients with severe acute tonsillitis 100 patients with peritonsillar cellulitis 50 patients with infectious mononucleosis
Key inclusion criteria (2 listed)
- Patients referred to our tertiary care center with acute tonsillitis with or without signs of peritonsillar cellulitis and with or without infectious mononucleosis.
- Center Score 3 or 4.
Key exclusion criteria (2 listed)
- Abscess formation.
- Previous tonsillectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Throat swabbingAlso: Blood sample | Other | Acute tonsillitis, Controls, Infectious mononucleosis, Peritonsillar cellulitis |
Primary outcome
Prevalence of Fusobacterium necrophorum in throat swab cultures
Time frame: At acute consultation (day 0)
4 secondary outcomes
Number of participants with recurrent throat infections (questionnaire)
Time frame: Six months after acute consultation
Number of participants without eradication of throat pathogens (throat cultures)
Time frame: 14-28 days after acute consultation
Number of participants with complications of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis
Time frame: 14-28 days after acute consultation
Prevalence of anti-Fusobacterium necrophorum antibody Development (two-fold or higher increase in antibody level) (blood samples)
Time frame: In acute and convalescent sera (day 0 and 14-28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Background: PubMed 24810966Klug TE, Henriksen JJ, Rusan M, Fuursted K, Krogfelt KA, Ovesen T, Struve C. Antibody development to Fusobacterium necrophorum in patients with peritonsillar abscess. Eur J Clin Microbiol Infect Dis. 2014 Oct;33(10):1733-9. doi: 10.1007/s10096-014-2130-y. Epub 2014 May 9.
- Background: PubMed 24474247Klug TE. Incidence and microbiology of peritonsillar abscess: the influence of season, age, and gender. Eur J Clin Microbiol Infect Dis. 2014 Jul;33(7):1163-7. doi: 10.1007/s10096-014-2052-8. Epub 2014 Jan 29.
- Background: PubMed 21181222Klug TE, Henriksen JJ, Fuursted K, Ovesen T. Significant pathogens in peritonsillar abscesses. Eur J Clin Microbiol Infect Dis. 2011 May;30(5):619-27. doi: 10.1007/s10096-010-1130-9. Epub 2010 Dec 22.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Tonsillitis and Peritonsillar Cellulitis, run by Tejs Ehlers Klug 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 2 inclusion and 2 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 22 Mar 2016. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Fusobacterium necrophorum in throat swab cultures (time frame: At acute consultation (day 0)). 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 NCT02715037, which also lists 4 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 22 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.