Status:
RECRUITING
Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis
Lead Sponsor:
University of Stellenbosch
Collaborating Sponsors:
New York University
Conditions:
TB - Tuberculosis
HIV/AIDS
Eligibility:
All Genders
18-60 years
Brief Summary
The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cau...
Detailed Description
The human body is host to complex microbial communities at different anatomical sites such as the gut, oral cavity, vagina, skin, and the lower respiratory tract - a site previously thought to be ster...
Eligibility Criteria
Inclusion
- 18-60 years old.
- Agree to undergo CXR and/or CT scan.
- Has unilateral TB disease defined as one lung with extensive evidence of TB disease (non-applicable to healthy controls; sick controls will require an alternative diagnosis).
- No evidence of prior TB treatment and/or CXR/CT does not have obvious evidence of prior TB.
- Willing to undergo a research bronchoscopy at baseline, 6 months and 18 months and likely to remain in the area for the study period.
- If HIV-positive, must be stable on antiretroviral therapy (ART) for ≥1 year.
- Able and willing to return for follow-up visits, with no plans to move in the near future.
- Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment.
Exclusion
- Less than 18 years or older than 60 years of age.
- Has already initiated TB treatment.
- Rifampicin resistant.
- Has a previous history of TB.
- Bilateral TB disease defined as both lungs with extensive TB disease
- Has received probiotics, antibiotics or inhaled steroids within three months prior to enrolment (not applicable to sick controls)
- Has diabetes mellitus, which affects TB disease, treatment response, and the microbiome
- Has a contraindication for bronchoscopy (e.g., FEV1 \<70%), as determined by bronchoscopists according to best practice guidelines
- Has a daily alcohol intake of more than 6 beers or 4 mixed drinks
- Is pregnant (a commercial human chorionic gonadotropin determination assay will be performed in accordance with manufacturer's guidance on urine) or pregnancy planned for follow-up period
- Recent hospitalization for any reason
Key Trial Info
Start Date :
March 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04700579
Start Date
March 4 2021
End Date
January 1 2026
Last Update
March 28 2024
Active Locations (3)
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1
Kraaifontein Community Health Centre
Cape Town, Western Cape, South Africa, 7570
2
Scottsdene Clinic
Cape Town, Western Cape, South Africa, 7570
3
Wallacedene Clinic
Cape Town, Western Cape, South Africa, 7570