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Gene Expression Profiles in Spinal Tuberculosis.

Recruitingn/aAges 18 Years - anyAllUniversity of Cape Town
NCT05610098 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, an

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Participant has completed the written informed consent process prior to undergoing any clinical evaluations and willing to undergo HIV testing 2. TB spine based on clinical and radiological criteria 3. Age 18 or older with a body weight of at least 40 kg body weight 4. Able and willing to return to follow-up 5. Willing to have samples, including DNA including RNA extraction, stored 6. Willing to consistently practice a highly reliable method of pregnancy prevention Exclusion Criteria 1. Pregnancy or active desire to become pregnant within the next 6 months. 2. Uncontrolled diabetes (HbA1c ≥ 6.5% / random glucose concentration ≥11.1 mmol/l, fasting plasma glucose ≥ 7.0 mmol/l) 3. Alcohol and substance abuse which might interfere with medication adherence during the trial 4. Positive SARS-CoV-2 PCR in the past 4 weeks 5. Suspicion of malignancy on MRI or known malignancy 6. Suspicion of inflammatory disease and other rheumatological conditions 7. Any person for whom the physician feels this study is not appropriate
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What it tests

  • Not listed
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Where

1 site
Groote Schuur Hospital
Cape Town, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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