Microbiology Studies of Acute Head and Neck Infections

• Conditions: Head and Neck Infection

• Registration Number: NCT05874908
• Lead Sponsor: The University of Northampton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Study Start: 2025-03-03
• Primary Completion: 2026-04-19
• Study Completion: 2026-04-19

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of Streptococci Species	4 years	Identification by DNA analysis of ribosomal ribonucleic acid (rRNA) genes and biochemical testing.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Northampton; 🇬🇧 Northampton, United Kingdom