Retropharyngeal AbscessNCT02640456
Microbiology of Para- og Retropharyngeal Abscess
An observational study of Retropharyngeal Abscess, run by Tejs Ehlers Klug at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retropharyngeal Abscess
- What is being tested?
- Bacteriology, Type of surgery and Biochemistry
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 5 sitesDenmark
- Study dates
- Apr 2016to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sixty patients with para- or retropharyngeal abscess. Twelve patients with neck abscess without relation to the pharynx or salivary glands (controls).
Who may be able to join
- para- or retropharyngeal abscess
Who cannot join
- refuse to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, Aalborg, 9100
Mirjana Ninn-Pedersen, MD, +45 40931367, mirjananinn@yahoo.dk
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus, 8000
Tejs E Klug, MD, +45 51604046, tejklu@rm.dk
- Recruiting
Hospitalsenheden Vest
Holstebro, Holstebro, 7500
Anne-Loiuse B Christensen, MD, +45 29932046, Anne.Louise.Christensen@auh.rm.dk
- Recruiting
Odense University Hospital
Odense, Odense, 5000
Anette D Kjeldsen, PhD, +45 23379822, anette.kjeldsen@rsyd.dk
- Recruiting
Sygehus Lillebaelt
Vejle, Vejle, 7100
Soren Fast, MD, Soeren.Fast1@rsyd.dk
About this study
Official title: Mikrobiologi Ved Para- og Retropharyngeal Absces
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.
Read the 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:
- 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.
- Conditions
- Retropharyngeal Abscess
- Being tested
- Bacteriology, Type of surgery, Biochemistry, Serology
- Keywords
- retropharyngeal abscess, parapharyngeal abscess, peritonsillar abscess, bacteriology, Fusobacterium necrophorum
- Medical subject headings
- Retropharyngeal Abscess, Peritonsillar Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BacteriologyBiological
Tonsillar surface swabs, tonsillar tissues, and pus aspirates.
Type of surgeryProcedure or surgery
Surgical approach and complications.
BiochemistryBiological
Amylase concentration i pus aspirates.
SerologyBiological
Levels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera.
| Study group | Role | What they receive |
|---|---|---|
| Para- or retropharyngeal abscess | Patients with para- or retropharyngeal abscess. Receives: Biological: Bacteriology; Procedure: Type of surgery; Biological: Biochemistry; Biological: Serology | |
| Neck abscess | Patients with neck abscess without relation to the pharynx or salivary glands. Receives: Biological: Biochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within eight hours of patient admission
Secondary outcomes (3)
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)
Measured: Within eight hours of patient admission (serum 1) and two to four weeks after admission (serum 2)
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).
Measured: Within eight hours of patient admission.
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.
Measured: Within eight hours of patient admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retropharyngeal AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tejs Ehlers Klug
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitalsenheden Vest, Aalborg University Hospital, Sygehus Lillebaelt, Aarhus University Hospital, Statens Serum Institut, University of Aarhus, Odense University Hospital
- Responsible party
- Sponsor-investigator, Tejs Ehlers Klug, Aarhus University Hospital
- Investigators
- Tejs E Klug, MD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640456
- Sponsor's protocol ID
- 51440
- Status last verified
- Apr 2016
- First submitted
- 15 Dec 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mikrobiologi Ved Para- og Retropharyngeal Absces
- ClinicalTrials.gov ID
- NCT02640456
- Acronym / sponsor ID
- 51440
- Conditions
- Retropharyngeal Abscess
- Keywords
- retropharyngeal abscess, parapharyngeal abscess, peritonsillar abscess, bacteriology, Fusobacterium necrophorum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tejs Ehlers KlugUniversity, hospital or other
- Collaborators
- Hospitalsenheden Vest, Aalborg University Hospital, Sygehus Lillebaelt, Aarhus University Hospital, Statens Serum Institut, University of Aarhus, Odense University Hospital
- Study start
- Apr 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Para- or retropharyngeal abscess | – | Biological: Bacteriology, Procedure: Type of surgery, Biological: Biochemistry, Biological: SerologyPatients with para- or retropharyngeal abscess. |
| Neck abscess | – | Biological: BiochemistryPatients with neck abscess without relation to the pharynx or salivary glands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty patients with para- or retropharyngeal abscess. Twelve patients with neck abscess without relation to the pharynx or salivary glands (controls).
Key inclusion criteria (1 listed)
- para- or retropharyngeal abscess
Key exclusion criteria (1 listed)
- refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BacteriologyTonsillar surface swabs, tonsillar tissues, and pus aspirates. | Biological | Para- or retropharyngeal abscess |
| Type of surgerySurgical approach and complications. | Procedure or surgery | Para- or retropharyngeal abscess |
| BiochemistryAmylase concentration i pus aspirates. | Biological | Neck abscess, Para- or retropharyngeal abscess |
| SerologyLevels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera. | Biological | Para- or retropharyngeal abscess |
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
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.
3 secondary outcomes
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)
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 bacterial recoveries in aerobic and anaerobic cultures from patients with concomitant peritonsillar and para-retropharyngeal abscess.
Time frame: Within eight hours of patient admission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejs E Klug, MD study chair
Aarhus University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retropharyngeal Abscess, run by Tejs Ehlers Klug at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tejs E Klug, MD (+45 51604046, tejklu@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.