Microbiology of Para- og Retropharyngeal Abscess
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ClinicalTrials.gov Identifier: NCT02640456 |
Recruitment Status : Unknown
Verified April 2016 by Tejs Ehlers Klug, Aarhus University Hospital.
Recruitment status was: Recruiting
First Posted : December 29, 2015
Last Update Posted : April 27, 2016
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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.
Condition or disease | Intervention/treatment |
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Retropharyngeal Abscess | Biological: Bacteriology Procedure: Type of surgery Biological: Biochemistry Biological: Serology |
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:
- 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).
- Level of statistical significance: P = 0.05
- Power: 90%.
- Part of F. necrophorum-positive para- or retropharyngeal patients WHO develop two-fold or higher anti-F. necrophorum antibody levels: 73%.
- 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:
- Amylase concentration > 20 U/L in 0% of controls.
- Amylase-concentration > 20 U/L in 50% af patients with para- or retropharyngeal abscess .
- Inclusion of controls 1:3 compared to patients with para- or retropharyngeal abscess .
- Level of statistical significance: P = 0.05
- Power: 90%. Number of para- or retropharyngeal patients needed: 36. Number of controls needed: 12.
Study Type : | Observational |
Estimated Enrollment : | 72 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Mikrobiologi Ved Para- og Retropharyngeal Absces |
Study Start Date : | April 2016 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | January 2020 |
Group/Cohort | Intervention/treatment |
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Para- or retropharyngeal abscess
Patients with para- or retropharyngeal abscess.
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Biological: Bacteriology
Tonsillar surface swabs, tonsillar tissues, and pus aspirates. Procedure: Type of surgery Surgical approach and complications. Biological: Biochemistry Amylase concentration i pus aspirates. Biological: Serology Levels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera. |
Neck abscess
Patients with neck abscess without relation to the pharynx or salivary glands.
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Biological: Biochemistry
Amylase concentration i pus aspirates. |
- 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.
- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- para- or retropharyngeal abscess
Exclusion Criteria:
- refuse to participate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640456
Contact: Tejs E Klug, MD | +45 51604046 | tejklu@rm.dk |
Denmark | |
Aalborg University Hospital | Recruiting |
Aalborg, Denmark, 9100 | |
Contact: Mirjana Ninn-Pedersen, MD +45 40931367 mirjananinn@yahoo.dk | |
Aarhus University Hospital | Recruiting |
Aarhus, Denmark, 8000 | |
Contact: Tejs E Klug, MD +45 51604046 tejklu@rm.dk | |
Hospitalsenheden Vest | Recruiting |
Holstebro, Denmark, 7500 | |
Contact: Anne-Loiuse B Christensen, MD +45 29932046 Anne.Louise.Christensen@auh.rm.dk | |
Odense University Hospital | Recruiting |
Odense, Denmark, 5000 | |
Contact: Anette D Kjeldsen, PhD +45 23379822 anette.kjeldsen@rsyd.dk | |
Sygehus Lillebaelt | Recruiting |
Vejle, Denmark, 7100 | |
Contact: Soren Fast, MD Soeren.Fast1@rsyd.dk |
Study Chair: | Tejs E Klug, MD | Aarhus University Hospital |
Responsible Party: | Tejs Ehlers Klug, Consultant, associate professor, Aarhus University Hospital |
ClinicalTrials.gov Identifier: | NCT02640456 |
Other Study ID Numbers: |
51440 |
First Posted: | December 29, 2015 Key Record Dates |
Last Update Posted: | April 27, 2016 |
Last Verified: | April 2016 |
retropharyngeal abscess parapharyngeal abscess peritonsillar abscess bacteriology Fusobacterium necrophorum |
Abscess Retropharyngeal Abscess Suppuration Infection Inflammation Pathologic Processes |
Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |