Head and Neck InfectionNCT05874908
Microbiology Studies of Acute Head and Neck Infections
An observational study of Head and Neck Infection, run by The University of Northampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Infection
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2025to 19 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with acute head and neck infections at Northampton General Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Head and Neck Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Streptococci Species
Identification by DNA analysis of ribosomal ribonucleic acid (rRNA) genes and biochemical testing.
Measured: 4 years
Secondary outcomes (6)
Patient Characteristics
Age in years. All measurements will be combined to determine common traits in acute head and neck infections.
Measured: 4 Years
Patient Characteristics
Sex as biological gender. All measurements will be combined to determine common traits in acute head and neck infections.
Measured: 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.
Measured: 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.
Measured: 4 Years
Clinical Outcomes
Antibiotic treatment in medication type. All measurements will be combined to determine common traits in acute head and neck infections.
Measured: 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.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start3 Mar 2025
- Primary completion19 Apr 2026
- Study completion19 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Northampton
- Sponsor type
- University, hospital or other
- Collaborators
- Northampton General Hospital NHS Trust
- Responsible party
- Principal investigator, Jazmine Cox, The University of Northampton
- Investigators
- Alexandra Woodacre, PhD, BSc, Principal investigator, University of Northampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874908
- Sponsor's protocol ID
- UNorthampton FAST PhD
- Status last verified
- Sep 2026
- First submitted
- 8 May 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only share pseudonymised data of participant/clinical outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Microorganisms Responsible for Acute Head and Neck Infections.
- ClinicalTrials.gov ID
- NCT05874908
- Acronym / sponsor ID
- UNorthampton FAST PhD
- Conditions
- Head and Neck Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The University of NorthamptonUniversity, hospital or other
- Collaborators
- Northampton General Hospital NHS Trust
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 19 Apr 2026 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with acute head and neck infections at Northampton General Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of Streptococci Species
Time frame: 4 years
Identification by DNA analysis of ribosomal ribonucleic acid (rRNA) genes and biochemical testing.
6 secondary outcomes
Patient Characteristics
Time frame: 4 Years
Patient Characteristics
Time frame: 4 Years
Patient Characteristics
Time frame: 4 Years
Clinical Outcomes
Time frame: 4 Years
Clinical Outcomes
Time frame: 4 Years
Clinical Outcomes
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Access to dataset, results summary, Doctor of Philosophy (PhD) thesis, publications and impact.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only share pseudonymised data of participant/clinical outcomes.
Related trials for Head and Neck Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Woodacre, PhD, BSc principal investigator
University of Northampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Infection, run by The University of Northampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Streptococci Species (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.