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Status unknownNCT02640456Updated Apr 27, 2016

Microbiology of Para- og Retropharyngeal Abscess

An observational study in Retropharyngeal Abscess, sponsored by Tejs Ehlers Klug. Status unknown at 5 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-27.

Sponsored by Tejs Ehlers Klug · Observational

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
72
Ages
18 Years and older
Sex
All
01

Study summary

The aims of the study are:

  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.
Read the detailed description

Patients:

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.
02

Conditions studied

  • Retropharyngeal Abscess

Keywords

  • retropharyngeal abscess
  • parapharyngeal abscess
  • peritonsillar abscess
  • bacteriology
  • Fusobacterium necrophorum
03

In context

Lead sponsor

Tejs Ehlers Klug is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Sixty patients with para- or retropharyngeal abscess. Twelve patients with neck abscess without relation to the pharynx or salivary glands (controls).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • para- or retropharyngeal abscess

Exclusion criteria

Exclusion Criteria:

  • refuse to participate
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
72 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Para- or retropharyngeal abscess

    Patients with para- or retropharyngeal abscess.

    Biological: Bacteriology · Procedure: Type of surgery · Biological: Biochemistry · Biological: Serology

  • Neck abscess

    Patients with neck abscess without relation to the pharynx or salivary glands.

    Biological: Biochemistry

Interventions

  • BiologicalBacteriology

    Tonsillar surface swabs, tonsillar tissues, and pus aspirates.

  • ProcedureType of surgery

    Surgical approach and complications.

  • BiologicalBiochemistry

    Amylase concentration i pus aspirates.

  • BiologicalSerology

    Levels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera.

06

What researchers measure

Primary outcomes

  1. Bacterial findings in aerobic and anaerobic cultures and MALDI-TOF mass spectrometry from para- and retropharyngeal abscesses

    Prevalence of potential bacterial pathogens (F. necrophorum, F. nucleatum, Prevotella species, Group A streptococcus, Group C/G streptococcus (large colony forming), S. aureus, H. influenzae, and Viridans streptococci) recovered from aerobic and anaerobic bacterial cultures from pus aspirates.

    Time frame: Within eight hours of patient admission

Secondary outcomes

  1. Antibody Development against F. necrophorum, F. nucleatum, and S. pyogenes in patients with para- and retropharyngeal abscess

    Prevalence of patients with antibody development (at least two-fold increase of antibody level) against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci)

    Time frame: Within eight hours of patient admission (serum 1) and two to four weeks after admission (serum 2)

  2. Amylase concentrations in para- and retropharyngeal abscesses vs neck abscesses without relation to the pharynx or salivary glands

    Comparison of amylase concentration i pus aspirates between patients with para- and retropharyngeal abscess versus patients with neck abscess not related to the pharynx or salivary glands (controls).

    Time frame: Within eight hours of patient admission.

  3. Comparison of bacterial recoveries in aerobic and anaerobic cultures from patients with concomitant peritonsillar and para-retropharyngeal abscess.

    Comparison of prevalence of potential bacterial pathogens (F. necrophorum, F. nucleatum, Prevotella species, Group A streptococcus, Group C/G streptococcus (large colony forming), S. aureus, H. influenzae, and Viridans streptococci) recovered from aerobic and anaerobic bacterial cultures from pus aspirates between concomitant peritonsillar and para-retropharyngeal abscesses.

    Time frame: Within eight hours of patient admission.

07

Study locations

5 of 5 sites recruiting
  • Aalborg University Hospital
    Aalborg, Aalborg 9100, Denmark
    Recruiting
  • Aarhus University Hospital
    Aarhus, Aarhus 8000, Denmark
    Recruiting
  • Hospitalsenheden Vest
    Holstebro, Holstebro 7500, Denmark
    Recruiting
  • Odense University Hospital
    Odense, Odense 5000, Denmark
    Recruiting
  • Sygehus Lillebaelt
    Vejle, Vejle 7100, Denmark
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02640456
Lead sponsor
Tejs Ehlers Klug
Collaborators
Hospitalsenheden Vest, Aalborg University Hospital, Sygehus Lillebaelt, Aarhus University Hospital, Statens Serum Institut, University of Aarhus, Odense University Hospital
Responsible party
Tejs Ehlers Klug (Consultant, associate professor, Aarhus University Hospital) — Sponsor-investigator
First posted
Dec 29, 2015
Start date
Apr 2016
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Apr 27, 2016

Study contacts

Tejs E Klug, MD
Contact
tejklu@rm.dk
+45 51604046
Tejs E Klug, MD
study chair · Aarhus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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