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Microbiology of Para- og Retropharyngeal Abscess

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ClinicalTrials.gov Identifier: NCT02640456
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : April 27, 2016
Sponsor:
Collaborators:
Hospitalsenheden Vest
Aalborg University Hospital
Sygehus Lillebaelt
Aarhus University Hospital
Statens Serum Institut
University of Aarhus
Odense University Hospital
Information provided by (Responsible Party):
Tejs Ehlers Klug, Aarhus University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Retropharyngeal Abscess Biological: Bacteriology Procedure: Type of surgery Biological: Biochemistry Biological: Serology

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 Design
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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mikrobiologi Ved Para- og Retropharyngeal Absces
Study Start Date : April 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  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).

  3. 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.


Biospecimen Retention:   Samples With DNA
Tonsillar surface swabs, pus aspirates, tonsillar tissues, sera

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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).
Criteria

Inclusion Criteria:

  • para- or retropharyngeal abscess

Exclusion Criteria:

  • refuse to participate
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640456


Contacts
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Contact: Tejs E Klug, MD +45 51604046 tejklu@rm.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9100
Contact: Mirjana Ninn-Pedersen, MD    +45 40931367    mirjananinn@yahoo.dk   
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Tejs E Klug, MD    +45 51604046    tejklu@rm.dk   
Hospitalsenheden Vest Recruiting
Holstebro, Denmark, 7500
Contact: Anne-Loiuse B Christensen, MD    +45 29932046    Anne.Louise.Christensen@auh.rm.dk   
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Anette D Kjeldsen, PhD    +45 23379822    anette.kjeldsen@rsyd.dk   
Sygehus Lillebaelt Recruiting
Vejle, Denmark, 7100
Contact: Soren Fast, MD       Soeren.Fast1@rsyd.dk   
Sponsors and Collaborators
Tejs Ehlers Klug
Hospitalsenheden Vest
Aalborg University Hospital
Sygehus Lillebaelt
Aarhus University Hospital
Statens Serum Institut
University of Aarhus
Odense University Hospital
Investigators
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Study Chair: Tejs E Klug, MD Aarhus University Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: Tejs Ehlers Klug, Consultant, associate professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02640456     History of Changes
Other Study ID Numbers: 51440
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Keywords provided by Tejs Ehlers Klug, Aarhus University Hospital:
retropharyngeal abscess
parapharyngeal abscess
peritonsillar abscess
bacteriology
Fusobacterium necrophorum
Additional relevant MeSH terms:
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Abscess
Retropharyngeal Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
 Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases