Clinical trial NCT02640456: Microbiology of Para- og Retropharyngeal Abscess
Official title: Mikrobiologi Ved Para- og Retropharyngeal Absces
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retropharyngeal Abscess
Keywords: retropharyngeal abscess
parapharyngeal abscess
peritonsillar abscess
bacteriology
Fusobacterium necrophorum
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Hospitalsenheden Vest
name: Aalborg University Hospital
name: Sygehus Lillebaelt
name: Aarhus University Hospital
name: Statens Serum Institut
name: University of Aarhus
name: Odense University Hospital
First posted: 2015-12-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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 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.

Eligibility criteria: Inclusion Criteria:

* para- or retropharyngeal abscess

Exclusion Criteria:

* refuse to participate

Primary outcomes:
measure: Bacterial findings in aerobic and anaerobic cultures and MALDI-TOF mass spectrometry from para- and retropharyngeal abscesses
timeFrame: Within eight hours of patient admission
Secondary outcomes:
measure: Antibody Development against F. necrophorum, F. nucleatum, and S. pyogenes in patients with para- and retropharyngeal abscess
timeFrame: Within eight hours of patient admission (serum 1) and two to four weeks after admission (serum 2)
measure: Amylase concentrations in para- and retropharyngeal abscesses vs neck abscesses without relation to the pharynx or salivary glands
timeFrame: Within eight hours of patient admission.
measure: Comparison of bacterial recoveries in aerobic and anaerobic cultures from patients with concomitant peritonsillar and para-retropharyngeal abscess.
timeFrame: Within eight hours of patient admission.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Holstebro
country: Denmark
facility: Hospitalsenheden Vest
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Sygehus Lillebaelt
Study officials:
affiliation: Aarhus University Hospital
name: Tejs E Klug, MD
role: STUDY_CHAIR
References: