NCT06526689Recruiting
Lung Innate Immunity and Microbiome After Tuberculosis Exposure
Investigating the Impact of the Pulmonary Innate Immune Response and Microbiome After Exposure to Mycobacterium Tuberculosis
Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To characterise the innate pulmonary immune response and respiratory microbiome after recent exposure to M.tb and to evaluate how differences determine the outcome of M.tb exposure
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 15 May 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- University of Oxford
- Diseases
- Tuberculosis
- NCT number
- NCT06526689
What you commit to
- Study type: Observational
- Planned participants: 50
- From 15 Aug 2024 to the primary completion date, 1 Oct 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
- Previous diagnosis or treatment for TB disease or latent TB infection
- Previous receipt of any investigational TB vaccines or aerosolised BCG.
- Concurrent use of oral, inhaled or systemic steroid medication or use for more than 14 days within the last 6 months (steroids used as a cream or ointment are permissible), or the use of other immunosuppressive agents concurrently or for more than 14 days within the last 6 months
- Administration of a live vaccine within the preceding 28 days prior to enrolment.
- Administration of any other non-live vaccine within the preceding 14 days prior to enrolment.
- History of close contact with case of TB, or previous contact tracing by TB services.
Other illness
- History of anaphylaxis or any allergy likely to be exacerbated by any essential study procedure
- History of currently poorly controlled of airways disease (including asthma), current cancer (except BCC of the skin or CIS of the cervix), bleeding disorder, or drug or alcohol abuse
- Any significant autoimmune conditions or immunodeficiency (including HIV)
- Any other significant disease, disorder, or finding, which, in the opinion of the investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the study or impair interpretation of the study data
- Group C Specific Exclusion Criteria
Lab values
- Clinical, radiological, or laboratory evidence of current active TB disease
Other
- Clinically Significant abnormalities in spirometry.
- Use of antibiotics in the past 4 weeks.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned study
- Pregnancy or intention to become pregnant during study period
Who the study is looking for
- Adults aged 18-65 years
- Resident in or near London or Oxford for the duration of the study period
- Provide written informed consent
- Willing to allow the investigators to review the volunteer's review NHS care record, medical history, blood results and radiographs.
- Able and willing (in the investigator's opinion) to comply with all study requirements
- Group A and B Specific Inclusion Criteria
- Have undergone screening for TB through NHS services (including IGRA testing +/- CXR where indicated)
- Close contact with a sputum smear positive TB case within the last 12 weeks
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grove Building, Royal Free NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Centre for Clinical Vaccinology and Tropical Medicine Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.