Gene Expression Profiles in Spinal Tuberculosis.

Launched by UNIVERSITY OF CAPE TOWN · Nov 7, 2022

Keywords

ClinConnect Summary

This clinical trial, called the Spinal TB X cohort, is studying spinal tuberculosis, a serious infection that affects the spine and can lead to severe health issues. Tuberculosis (TB) is a global health concern, and while most attention has been on lung TB, spinal TB is often overlooked despite being a significant problem. The goal of this study is to better understand how spinal TB affects patients by looking at specific gene profiles and using advanced imaging techniques. Ultimately, the researchers hope to develop a blood test that can help diagnose spinal TB earlier, which could lead to better treatment outcomes for patients.

To be eligible for this trial, participants need to be at least 18 years old, have a confirmed case of spinal TB based on medical tests, and be willing to undergo HIV testing. They should also be able to return for follow-up visits and agree to provide blood samples for research. However, individuals who are pregnant or planning to become pregnant soon, have uncontrolled diabetes, or certain other health conditions may not be able to participate. Participants can expect to undergo various tests and assessments during the study, and their involvement will contribute to improving the understanding and treatment of spinal TB.

Gender

ALL

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