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Microbiology of Para- og Retropharyngeal Abscess

Mikrobiologi Ved Para- og Retropharyngeal Absces

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02640456
Enrollment
72
Registered
2015-12-29
Start date
2016-04-30
Completion date
2020-01-31
Last updated
2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retropharyngeal Abscess

Keywords

retropharyngeal abscess, parapharyngeal abscess, peritonsillar abscess, bacteriology, Fusobacterium necrophorum

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.

Interventions

BIOLOGICALBacteriology

Tonsillar surface swabs, tonsillar tissues, and pus aspirates.

Surgical approach and complications.

BIOLOGICALBiochemistry

Amylase concentration i pus aspirates.

BIOLOGICALSerology

Levels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera.

Sponsors

Hospitalsenheden Vest
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Sygehus Lillebaelt
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Statens Serum Institut
CollaboratorOTHER
University of Aarhus
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Tejs Ehlers Klug
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* para- or retropharyngeal abscess

Exclusion criteria

* refuse to participate

Design outcomes

Primary

MeasureTime frameDescription
Bacterial findings in aerobic and anaerobic cultures and MALDI-TOF mass spectrometry from para- and retropharyngeal abscessesWithin eight hours of patient admissionPrevalence 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

MeasureTime frameDescription
Antibody Development against F. necrophorum, F. nucleatum, and S. pyogenes in patients with para- and retropharyngeal abscessWithin 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 glandsWithin 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.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.

Countries

Denmark

Contacts

Primary ContactTejs E Klug, MD
tejklu@rm.dk+45 51604046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026