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:
- Explore the bacteriology of para- and retropharyngeal abscess.
- Validate the bacterial findings by exploring antibody development against F. necrophorum, F. nucleatum and S. pyogenes.
- Compare bacteriologic findings in concomitant peritonsillar and parapharyngeal abscesses.
- Characterize patients with para- and retropharyngeal abscess.
- Compare the concentration of amylase in para- and retropharyngeal abscesses and neck abscesses without relation to the pharynx or salivary glands.
- 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:
- Tonsillar surface swabs (bilaterally)
- Pus aspirate from para- or retropharyngeal abscess
- Pus aspirate from peritonsillar abscess, if present
- Biopsy or the entire tonsil (bilaterally)
- Blood samples (acute and convalescent)
Investigations:
- Bacterial cultures from tonsillar surface swabs, pus aspirates, and tonsillar tissues.
- Antibody development against F. necrophorum, F. nucleatum and S. pyogenes from the two sera.
- Gene-sequencing of F. Necrophorum strains.
- 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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- 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.
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 ]
Original Primary Outcome: Bacterial findings in aerobic and anaerobic cultures from para- and retropharyngeal abscesses [ Time Frame: Within eight hours of patient admission ]
Current Secondary Outcome:
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