Microbiology of Para- og Retropharyngeal Abscess

April 26, 2016 updated by: Tejs Ehlers Klug

Mikrobiologi Ved Para- og Retropharyngeal Absces

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Recruiting
        • Aalborg University Hospital
        • Contact:
      • Aarhus, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Tejs E Klug, MD
          • Phone Number: +45 51604046
          • Email: tejklu@rm.dk
      • Holstebro, Denmark, 7500
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:
      • Vejle, Denmark, 7100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

  • para- or retropharyngeal abscess

Exclusion Criteria:

  • refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Para- or retropharyngeal abscess
Patients with para- or retropharyngeal abscess.
Biological: Bacteriology
Tonsillar surface swabs, tonsillar tissues, and pus aspirates.
Procedure: Type of surgery
Surgical approach and complications.
Biological: Biochemistry
Amylase concentration i pus aspirates.
Biological: 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.
Biological: Biochemistry
Amylase concentration i pus aspirates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial findings in aerobic and anaerobic cultures and MALDI-TOF mass spectrometry from para- and retropharyngeal abscesses
Time Frame: Within eight hours of patient admission
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.
Within eight hours of patient admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody Development against F. necrophorum, F. nucleatum, and S. pyogenes in patients with para- and retropharyngeal abscess
Time Frame: Within eight hours of patient admission (serum 1) and two to four weeks after admission (serum 2)
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)
Within eight hours of patient admission (serum 1) and two to four weeks after admission (serum 2)
Amylase concentrations in para- and retropharyngeal abscesses vs neck abscesses without relation to the pharynx or salivary glands
Time Frame: Within eight hours of patient admission.
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).
Within eight hours of patient admission.
Comparison of bacterial recoveries in aerobic and anaerobic cultures from patients with concomitant peritonsillar and para-retropharyngeal abscess.
Time Frame: Within eight hours of patient admission.
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.
Within eight hours of patient admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tejs Ehlers Klug

Collaborators

Odense University Hospital
Aarhus University Hospital
University of Aarhus
Aalborg University Hospital
Sygehus Lillebaelt
Statens Serum Institut
Hospitalsenheden Vest

Investigators

  • Study Chair: Tejs E Klug, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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