Microbiology Studies of Acute Head and Neck Infections

Sponsor
The University of Northampton (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05874908
Collaborator
Northampton General Hospital NHS Trust (Other)
150
1
48
3.1

Study Details

Study Description

Brief Summary

Acute head and neck infections cause significant pain and discomfort for patients and impact on their quality of life. Effective antibiotic and surgical treatments have been developed for these infections but they are still able to develop into life-threatening diseases such as meningitis and sepsis. The direct cause of acute head and neck infections is often unknown but it has been suggested that they are due to a disturbance of the normal bacterial growing in the mouth or are from dental origin.

The most common microorganisms identified from these infections in published studies are a group of bacteria known as viridans group streptococci (VGS). There are over 30 individual species of bacteria in the viridans group and VGS are difficult to identify to the level of a single species because of their variability. There is a lack of species identification within the hospital setting and this project aims to gain a deeper understanding of the microorganisms causing acute head and neck infections, focusing on identification of individual species of VGS bacteria.

The investigators will analyse bacterial DNA to determine which species have been identified and will also look at patient data and clinical outcomes (eg. length of hospital stay) to determine if the species causing the infection has any effect on patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identifying the Microorganisms Responsible for Acute Head and Neck Infections.
    Actual Study Start Date :
    Oct 19, 2021
    Anticipated Primary Completion Date :
    Oct 19, 2025
    Anticipated Study Completion Date :
    Oct 19, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Identification of Streptococci Species [4 years]

      Identification by DNA analysis of ribosomal ribonucleic acid (rRNA) genes and biochemical testing.

    Secondary Outcome Measures

    1. Patient Characteristics [4 Years]

      Age in years. All measurements will be combined to determine common traits in acute head and neck infections.

    2. Patient Characteristics [4 Years]

      Sex as biological gender. All measurements will be combined to determine common traits in acute head and neck infections.

    3. Patient Characteristics [4 Years]

      Site of Infection in areas of the head and neck. All measurements will be combined to determine common traits in acute head and neck infections.

    4. Clinical Outcomes [4 Years]

      Length of hospital stay in days. All measurements will be combined to determine common traits in acute head and neck infections.

    5. Clinical Outcomes [4 Years]

      Antibiotic treatment in medication type. All measurements will be combined to determine common traits in acute head and neck infections.

    6. Clinical Outcomes [4 Years]

      Diabetic diagnosis in diabetic/non-diabetic. All measurements will be combined to determine common traits in acute head and neck infections.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Over the age of 18

    • Suffering with acute head and neck infection of Streptococci.

    • Samples must come from Northampton General Hospital.

    • Consent to participate in research with at least 24 hours of consideration.

    Exclusion Criteria:
    • Age <18 years.

    • Samples from other National Health Service (NHS) hospitals.

    • Infections from other areas of the body.

    • Infection identified as caused by non-streptococcal bacteria.

    • Chosen not to participate in research.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Northampton Northampton United Kingdom NN1 5PH

    Sponsors and Collaborators

    • The University of Northampton
    • Northampton General Hospital NHS Trust

    Investigators

    • Principal Investigator: Alexandra Woodacre, PhD, BSc, University of Northampton

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jazmine Cox, Principal Investigator, The University of Northampton
    ClinicalTrials.gov Identifier:
    NCT05874908
    Other Study ID Numbers:
    • UNorthampton FAST PhD
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 25, 2023