Head and Neck Infection Clinical Trial
Official title:
Identifying the Microorganisms Responsible for Acute Head and Neck Infections.
| Verified date | May 2023 |
| Source | The University of Northampton |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Enrolling by invitation |
| Enrollment | 150 |
| Est. completion date | October 19, 2025 |
| Est. primary completion date | October 19, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Northampton | Northampton |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Northampton | Northampton General Hospital NHS Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Identification of Streptococci Species | Identification by DNA analysis of ribosomal ribonucleic acid (rRNA) genes and biochemical testing. | 4 years | |
| Secondary | Patient Characteristics | Age in years. All measurements will be combined to determine common traits in acute head and neck infections. | 4 Years | |
| Secondary | Patient Characteristics | Sex as biological gender. All measurements will be combined to determine common traits in acute head and neck infections. | 4 Years | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Clinical Outcomes | Antibiotic treatment in medication type. All measurements will be combined to determine common traits in acute head and neck infections. | 4 Years | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03048513 -
Clinical Presentation of Melioidosis in Head and Neck Region
|
N/A |