Gene expression profiles in spinal tuberculosis

Comparing Gene Expression Profiles of Adults With Isolated Spinal TB to Disseminated Spinal TB Identified by 18FDG-PET/CT at Time of Diagnosis, 6-and 12-months Follow-up

This study is trying to see if different gene patterns in spinal tuberculosis can help doctors better understand and treat the disease, especially in people with HIV.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Cape Town (other)
• Locations: 1 site (Cape Town, Western Cape)
• Trial ID: NCT05610098 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the clinical phenotype of spinal tuberculosis (TB) using whole body PET/CT imaging and to identify specific gene expression profiles associated with different stages of the disease. The researchers hypothesize that spinal TB can present as either isolated or disseminated forms, and that these can be distinguished by gene expression patterns. By comparing findings with previously established signatures for pulmonary TB, the study seeks to improve diagnostic methods and treatment monitoring for spinal TB, particularly in populations with high HIV prevalence.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with spinal tuberculosis based on clinical and radiological criteria.

Not a fit: Patients who are pregnant or have uncontrolled diabetes, active malignancies, or other significant inflammatory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and improved treatment outcomes for patients with spinal tuberculosis.

How similar studies have performed: While there have been studies on pulmonary TB, this approach focusing specifically on spinal TB and its gene expression profiles is relatively novel and has not been extensively tested.

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

Where this trial is running

Cape Town, Western Cape

• Groote Schuur Hospital — Cape Town, Western Cape, South Africa (RECRUITING)

Study contacts

• Principal investigator: friedrich Thienemann, MD — University of Cape Town
• Study coordinator: Friedrich F Thienemann, MD

Conditions: Tuberculosis, Spinal, Tuberculosis, Osteoarticular, Tuberculosis, Mycobacterium Infections, Infections, Bone Diseases, Infectious, Musculoskeletal Diseases, Spinal Disease