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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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Grove Building, Royal Free NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Churchill Hospital
Coordinator of this site? Confirm its status
OxfordUnited KingdomRecruiting
Centre for Clinical Vaccinology and Tropical Medicine
Coordinator of this site? Confirm its status
OxfordUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.