NCT05610098 Gene Expression Profiles in Spinal Tuberculosis.
| NCT ID | NCT05610098 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cape Town |
| Condition | Tuberculosis, Spinal |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-10-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
friedrich Thienemann, MD
PRINCIPAL INVESTIGATOR
University of Cape Town
Frequently Asked Questions
Who can join the NCT05610098 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculosis, Spinal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05610098 currently recruiting?
Yes, NCT05610098 is actively recruiting participants. Contact the research team at friedrich.thienemann@uct.ac.za for enrollment information.
Where is the NCT05610098 trial being conducted?
This trial is being conducted at Cape Town, South Africa.
Who is sponsoring the NCT05610098 clinical trial?
NCT05610098 is sponsored by University of Cape Town. The principal investigator is friedrich Thienemann, MD at University of Cape Town. The trial plans to enroll 100 participants.