Microbiology Studies of Acute Head and Neck Infections

Identifying the Microorganisms Responsible for Acute Head and Neck Infections.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Head and Neck Infection

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United Kingdom
  • Northampton, United Kingdom, NN1 5PH
    • University of Northampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute head and neck infections at Northampton General Hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of Streptococci Species	Identification by DNA analysis of ribosomal ribonucleic acid (rRNA) genes and biochemical testing.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Characteristics	Age in years. All measurements will be combined to determine common traits in acute head and neck infections.	4 Years
Patient Characteristics	Sex as biological gender. All measurements will be combined to determine common traits in acute head and neck infections.	4 Years
Patient Characteristics	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 Years
Clinical Outcomes	Length of hospital stay in days. All measurements will be combined to determine common traits in acute head and neck infections.	4 Years
Clinical Outcomes	Antibiotic treatment in medication type. All measurements will be combined to determine common traits in acute head and neck infections.	4 Years
Clinical Outcomes	Diabetic diagnosis in diabetic/non-diabetic. All measurements will be combined to determine common traits in acute head and neck infections.	4 Years

Collaborators and Investigators

• Sponsor: The University of Northampton
• Collaborators: Northampton General Hospital NHS Trust
• Investigators: Principal Investigator: Alexandra Woodacre, PhD, BSc, University of Northampton

Publications and helpful links

Helpful Links

• Access to dataset, results summary, Doctor of Philosophy (PhD) thesis, publications and impact.

Study record dates

Study Major Dates

• Study Start (Estimated): March 3, 2025
• Primary Completion (Estimated): April 19, 2026
• Study Completion (Estimated): April 19, 2026

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: UNorthampton FAST PhD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only share pseudonymised data of participant/clinical outcomes.
• IPD Sharing Time Frame: October 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No