Microbiology Studies of Acute Head and Neck Infections

NCT05874908 | Enrolling By Invitation

• 1 other identifier: UNorthampton FAST PhD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Infection

Outcome Measures

Primary Outcomes (1)

• Identification of Streptococci Species

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

  4 years

Secondary Outcomes (6)

• Patient Characteristics

  4 Years

• Patient Characteristics

  4 Years

• Patient Characteristics

  4 Years

• Clinical Outcomes

  4 Years

• Clinical Outcomes

  4 Years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Northampton: lead
• Northampton General Hospital NHS Trust: collaborator

Study Sites (1)

University of Northampton

Northampton, NN1 5PH, United Kingdom

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacterial isolates from pus swabs.

Study Officials

• Alexandra Woodacre, PhD, BSc

  University of Northampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 25, 2023
• Study Start: March 3, 2025
• Primary Completion: April 19, 2026
• Study Completion: April 19, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: October 2025

Locations

GB (1)