Retropharyngeal Abscess Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 72 |
| Est. completion date | January 2020 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - para- or retropharyngeal abscess Exclusion Criteria: - refuse to participate |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aalborg University Hospital | Aalborg | |
| Denmark | Aarhus University Hospital | Aarhus | |
| Denmark | Hospitalsenheden Vest | Holstebro | |
| Denmark | Odense University Hospital | Odense | |
| Denmark | Sygehus Lillebaelt | Vejle |
| Lead Sponsor | Collaborator |
|---|---|
| Tejs Ehlers Klug | Aalborg Universitetshospital, Aarhus University Hospital, Hospitalsenheden Vest, Odense University Hospital, Statens Serum Institut, Sygehus Lillebaelt, University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Within eight hours of patient admission | No |
| Secondary | 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) | Within eight hours of patient admission (serum 1) and two to four weeks after admission (serum 2) | No |
| Secondary | 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). | Within eight hours of patient admission. | No |
| Secondary | 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. | Within eight hours of patient admission. | No |