Clinical Trial: Microbiology of Para- og Retropharyngeal Abscess

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Mikrobiologi Ved Para- og Retropharyngeal Absces

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.

Detailed Summary:

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:

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    Sponsor: Tejs Ehlers Klug

    Current Primary Outcome: 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.


    Original Primary Outcome: Bacterial findings in aerobic and anaerobic cultures 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.


    Current Secondary Outcome:

    • 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)
    • 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).
    • 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.


    Original Secondary Outcome: Same as current

    Information By: Aarhus University Hospital

    Dates:
    Date Received: December 15, 2015
    Date Started: April 2016
    Date Completion: January 2020
    Last Updated: April 26, 2016
    Last Verified: April 2016