Gene Expression Profiles in Spinal Tuberculosis.
- Conditions
- Tuberculosis, SpinalTuberculosisMycobacterium InfectionsInfectionsBone Diseases, InfectiousTuberculosis, OsteoarticularMusculoskeletal DiseasesSpinal DiseaseSpondylitisTuberculosis (Manifestation)
- Registration Number
- NCT05610098
- Lead Sponsor
- University of Cape Town
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria<br><br> 1. Participant has completed the written informed consent process prior to undergoing<br> any clinical evaluations and willing to undergo HIV testing<br><br> 2. TB spine based on clinical and radiological criteria<br><br> 3. Age 18 or older with a body weight of at least 40 kg body weight<br><br> 4. Able and willing to return to follow-up<br><br> 5. Willing to have samples, including DNA including RNA extraction, stored<br><br> 6. Willing to consistently practice a highly reliable method of pregnancy prevention<br><br>Exclusion Criteria<br><br> 1. Pregnancy or active desire to become pregnant within the next 6 months.<br><br> 2. Uncontrolled diabetes (HbA1c = 6.5% / random glucose concentration =11.1 mmol/l,<br> fasting plasma glucose = 7.0 mmol/l)<br><br> 3. Alcohol and substance abuse which might interfere with medication adherence during<br> the trial<br><br> 4. Positive SARS-CoV-2 PCR in the past 4 weeks<br><br> 5. Suspicion of malignancy on MRI or known malignancy<br><br> 6. Suspicion of inflammatory disease and other rheumatological conditions<br><br> 7. Any person for whom the physician feels this study is not appropriate
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical phenotype of spinal TB;mRNA gene expression profiles of spinal TB
- Secondary Outcome Measures
Name Time Method MRI vs. PET/CT at the site of disease (spine level);Whole Genome Sequencing of Mtb. isolates;PET/CT changes over 12 months