Study Results
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Basic Information
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UNKNOWN
72 participants
OBSERVATIONAL
2016-04-30
2020-01-31
Brief Summary
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1. Explore the bacteriology of para- and retropharyngeal abscess.
2. Validate the bacterial findings by exploring antibody development against F. necrophorum, F. nucleatum and S. pyogenes.
3. Compare bacteriologic findings in concomitant peritonsillar and parapharyngeal abscesses.
4. Characterize patients with para- and retropharyngeal abscess.
5. Compare the concentration of amylase in para- and retropharyngeal abscesses and neck abscesses without relation to the pharynx or salivary glands.
6. Perform gene-sequencing of F. Necrophorum strains, and compare these with strains recovered from patients with acute tonsillitis, peritonsillar abscess, and Lemierre´s syndrome.
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Detailed Description
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Sixty patients aged 18 years or older with para- or retropharyngeal abscess and 12 patients with neck abscess without relation to the pharynx or salivary glands (controls) will be included at five Danish centers. Estimated time of inclusion: Four years.
Data:
Symptoms, findings, and other relevant information will be obtained at admission. Data regarding treatment and complications will be obtained after discharge.
Samples:
1. Tonsillar surface swabs (bilaterally)
2. Pus aspirate from para- or retropharyngeal abscess
3. Pus aspirate from peritonsillar abscess, if present
4. Biopsy or the entire tonsil (bilaterally)
5. Blood samples (acute and convalescent)
Investigations:
1. Bacterial cultures from tonsillar surface swabs, pus aspirates, and tonsillar tissues.
2. Antibody development against F. necrophorum, F. nucleatum and S. pyogenes from the two sera.
3. Gene-sequencing of F. Necrophorum strains.
4. Measurement of amylase concentrations in pus aspirates.
Power calculations:
Patients needed to show significant increase in anti-F. necrophorum antibody development.
Assumptions:
1. The found anti-F. necrophorum antibody levels will be compared to previous findings in electively tonsillectomized patients (9 of 47 patients had two-fold or higher increase in anti-F. necrophorum antibody levels).
2. Level of statistical significance: P = 0.05
3. Power: 90%.
4. Part of F. necrophorum-positive para- or retropharyngeal patients WHO develop two-fold or higher anti-F. necrophorum antibody levels: 73%.
5. Part of para- or retropharyngeal patients with F. necrophorum: 20%. Number of para- or retropharyngeal patients needed: 60.
Concerning comparison of amylase concentrations between patients with para- or retropharyngeal abscess and patients with neck abscesses without relation to the pharynx or salivary glands:
Assumptions:
1. Amylase concentration \> 20 U/L in 0% of controls.
2. Amylase-concentration \> 20 U/L in 50% af patients with para- or retropharyngeal abscess .
3. Inclusion of controls 1:3 compared to patients with para- or retropharyngeal abscess .
4. Level of statistical significance: P = 0.05
5. Power: 90%. Number of para- or retropharyngeal patients needed: 36. Number of controls needed: 12.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Para- or retropharyngeal abscess
Patients with para- or retropharyngeal abscess.
Bacteriology
Tonsillar surface swabs, tonsillar tissues, and pus aspirates.
Type of surgery
Surgical approach and complications.
Biochemistry
Amylase concentration i pus aspirates.
Serology
Levels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera.
Neck abscess
Patients with neck abscess without relation to the pharynx or salivary glands.
Biochemistry
Amylase concentration i pus aspirates.
Interventions
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Bacteriology
Tonsillar surface swabs, tonsillar tissues, and pus aspirates.
Type of surgery
Surgical approach and complications.
Biochemistry
Amylase concentration i pus aspirates.
Serology
Levels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospitalsenheden Vest
OTHER
Aalborg University Hospital
OTHER
Sygehus Lillebaelt
OTHER
Aarhus University Hospital
OTHER
Statens Serum Institut
OTHER
University of Aarhus
OTHER
Odense University Hospital
OTHER
Tejs Ehlers Klug
OTHER
Responsible Party
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Tejs Ehlers Klug
Consultant, associate professor
Principal Investigators
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Tejs E Klug, MD
Role: STUDY_CHAIR
Aarhus University Hospital
Locations
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Aalborg University Hospital
Aalborg, Aalborg, Denmark
Aarhus University Hospital
Aarhus, Aarhus, Denmark
Hospitalsenheden Vest
Holstebro, Holstebro, Denmark
Odense University Hospital
Odense, Odense, Denmark
Sygehus Lillebaelt
Vejle, Vejle, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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51440
Identifier Type: -
Identifier Source: org_study_id
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