Actively Recruiting
Gene Expression Profiles in Spinal Tuberculosis.
Led by University of Cape Town · Updated on 2024-08-23
100
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
U
University of Cape Town
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Tuberculosis (TB) is one of the top ten causes of death worldwide with approximately 10 million cases globally and 1.2 million deaths. Sub-Saharan Africa carries the highest burden of TB. South Africa has one of the highest HIV and TB rates worldwide with an HIV prevalence rate in adults of 19% and a TB case notification rate of 615/100,000 in 2019. Over many years, focus has been paid to pulmonary TB and extrapulmonary TB (EPTB) has received only little attention even though it accounts for almost a quatre of all TB cases. The diagnosis of EPTB remains challenging simply because sample collection requires invasive procedures in the absence of a blood-based diagnostic test. Spinal TB (spondylitis or spondylodiscitis caused by Mycobacterium tuberculosis) - often known as Pott's disease - accounts for up to 10% of EPTB and affects young children, people with HIV-coinfection and elderly, and often leads to lifelong debilitating disease due to devastating deformation of the spine and compression of neural structures. Little is known with regards to the extent of disease and isolated TB spine as well as a disseminated form of TB spine have been described. The latter presents with a spinal manifestation plus disseminations to other organs such as the lungs, pleura, lymph nodes, the GIT or urinary tract or even the brain. In the Spinal TB X cohort, the investigators aim to describe the clinical phenotype of spinal TB using whole body PET/CT and identify a specific gene expression profile for the different stages of dissemination and compare findings to previously described signatures for latent and active pulmonary TB. A blood-based test for spinal TB would lead to earlier diagnosis and treatment in all settings globally and improve treatment outcome of this devastating disease.
CONDITIONS
Official Title
Gene Expression Profiles in Spinal Tuberculosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has completed the written informed consent process prior to undergoing any clinical evaluations and willing to undergo HIV testing
- TB spine based on clinical and radiological criteria
- Age 18 or older with a body weight of at least 40 kg body weight
- Able and willing to return to follow-up
- Willing to have samples, including DNA including RNA extraction, stored
- Willing to consistently practice a highly reliable method of pregnancy prevention
You will not qualify if you...
- Pregnancy or active desire to become pregnant within the next 6 months
- Uncontrolled diabetes (HbA1c 65 6.5% / random glucose concentration 6511.1 mmol/l, fasting plasma glucose 65 7.0 mmol/l)
- Alcohol and substance abuse which might interfere with medication adherence during the trial
- Positive SARS-CoV-2 PCR in the past 4 weeks
- Suspicion of malignancy on MRI or known malignancy
- Suspicion of inflammatory disease and other rheumatological conditions
- Any person for whom the physician feels this study is not appropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7935
Actively Recruiting
Research Team
F
Friedrich F Thienemann, MD
CONTACT
M
Michael Held, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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