Clinical trial NCT05874908: Microbiology Studies of Acute Head and Neck Infections
Official title: Identifying the Microorganisms Responsible for Acute Head and Neck Infections.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Head and Neck Infection
Lead sponsor: The University of Northampton
Sponsor class: OTHER
Collaborators: name: Northampton General Hospital NHS Trust
First posted: 2023-05-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute head and neck infections at Northampton General Hospital.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identification of Streptococci Species
timeFrame: 4 years
Secondary outcomes:
measure: Patient Characteristics
timeFrame: 4 Years
measure: Patient Characteristics
timeFrame: 4 Years
measure: Patient Characteristics
timeFrame: 4 Years
measure: Clinical Outcomes
timeFrame: 4 Years
measure: Clinical Outcomes
timeFrame: 4 Years
measure: Clinical Outcomes
timeFrame: 4 Years
Other outcomes:
Locations:
city: Northampton
country: United Kingdom
facility: University of Northampton
Study officials:
affiliation: University of Northampton
name: Alexandra Woodacre, PhD, BSc
role: PRINCIPAL_INVESTIGATOR
References: