NCT02640456

Brief Summary

The aims of the study are:

  1. 1.Explore the bacteriology of para- and retropharyngeal abscess.
  2. 2.Validate the bacterial findings by exploring antibody development against F. necrophorum, F. nucleatum and S. pyogenes.
  3. 3.Compare bacteriologic findings in concomitant peritonsillar and parapharyngeal abscesses.
  4. 4.Characterize patients with para- and retropharyngeal abscess.
  5. 5.Compare the concentration of amylase in para- and retropharyngeal abscesses and neck abscesses without relation to the pharynx or salivary glands.
  6. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

December 15, 2015

Last Update Submit

April 26, 2016

Conditions

Retropharyngeal Abscess

Keywords

retropharyngeal abscessparapharyngeal abscessperitonsillar abscessbacteriologyFusobacterium necrophorum

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Antibody Development against F. necrophorum, F. nucleatum, and S. pyogenes in patients with para- and retropharyngeal abscess

    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

    Within eight hours of patient admission.

  • Comparison of bacterial recoveries in aerobic and anaerobic cultures from patients with concomitant peritonsillar and para-retropharyngeal abscess.

    Within eight hours of patient admission.

Study Arms (2)

Para- or retropharyngeal abscess

Patients with para- or retropharyngeal abscess.

Biological: BacteriologyProcedure: Type of surgeryBiological: BiochemistryBiological: Serology

Neck abscess

Patients with neck abscess without relation to the pharynx or salivary glands.

Biological: Biochemistry

Interventions

BacteriologyBIOLOGICAL

Tonsillar surface swabs, tonsillar tissues, and pus aspirates.

Para- or retropharyngeal abscess
Type of surgeryPROCEDURE

Surgical approach and complications.

Para- or retropharyngeal abscess
BiochemistryBIOLOGICAL

Amylase concentration i pus aspirates.

Neck abscessPara- or retropharyngeal abscess
SerologyBIOLOGICAL

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

Para- or retropharyngeal abscess

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • para- or retropharyngeal abscess

You may not qualify if:

  • refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aalborg University Hospital

Aalborg, Aalborg, 9100, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

RECRUITING

Hospitalsenheden Vest

Holstebro, Holstebro, 7500, Denmark

RECRUITING

Odense University Hospital

Odense, Odense, 5000, Denmark

RECRUITING

Sygehus Lillebaelt

Vejle, Vejle, 7100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tonsillar surface swabs, pus aspirates, tonsillar tissues, sera

MeSH Terms

Conditions

Retropharyngeal AbscessPeritonsillar Abscess

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsAbscessSuppurationPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesTonsillitis

Study Officials

  • Tejs E Klug, MD

    Aarhus University Hospital

    STUDY CHAIR

Central Study Contacts

Tejs E Klug, MD

CONTACT

+45 51604046tejklu@rm.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, associate professor

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 29, 2015

Study Start

April 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

DK(5)