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OpenTrials
Enrolling by Invitation

NCT Number: NCT05874908

Microbiology Studies of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Northampton

Northampton, NN1 5PH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Identification of Streptococci Species

    Time frame: 4 years

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

Secondary outcomes

  1. Patient Characteristics

    Time frame: 4 Years

    Age in years. All measurements will be combined to determine common traits in acute head and neck infections.

  2. Patient Characteristics

    Time frame: 4 Years

    Sex as biological gender. All measurements will be combined to determine common traits in acute head and neck infections.

  3. Patient Characteristics

    Time frame: 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.

  4. Clinical Outcomes

    Time frame: 4 Years

    Length of hospital stay in days. All measurements will be combined to determine common traits in acute head and neck infections.

  5. Clinical Outcomes

    Time frame: 4 Years

    Antibiotic treatment in medication type. All measurements will be combined to determine common traits in acute head and neck infections.

  6. Clinical Outcomes

    Time frame: 4 Years

    Diabetic diagnosis in diabetic/non-diabetic. All measurements will be combined to determine common traits in acute head and neck infections.

Sponsors and collaborators

Lead sponsor

The University of Northampton

Other

Collaborators

  • Northampton General Hospital NHS Trust

Registry information

Official study title

Identifying the Microorganisms Responsible for Acute Head and Neck Infections.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.