Phase 2 Tuberculosis Trial, Recruiting NCT04521803 Sponsor: University of Cape Town Condition: Tuberculosis
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Phase 2 Tuberculosis Trial, Recruiting

NCT04521803
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged over 18 years
  • People with suspected tuberculosis of the sac around the heart (pericardium), with fluid around the heart confirmed by an ultrasound scan (echocardiogram)
  • People who agree to take part in the study, including agreeing to an HIV test if their HIV status is not already known
  • People where tuberculosis bacteria have been found in the fluid around the heart, or where tuberculosis of the pericardium is considered probable based on specific medical criteria — either tuberculosis confirmed elsewhere in the body alongside signs of pericarditis, or certain characteristics of the pericardial fluid (confirm with trial site for full details)
  • People who are scheduled to have a procedure to drain the fluid from around the heart (pericardiocentesis), based on their clinical need
  • People who are within 5 days of starting tuberculosis drug treatment

Who may not be able to join:

  • People whose kidneys are not working well enough (low filtration rate under 30ml/min) or who need dialysis
  • People whose tuberculosis is resistant to the drug Rifampin
  • People with a serious additional infection occurring at the same time
  • People for whom placing a drainage tube into the sac around the heart is not medically appropriate
  • People in whom the fluid drainage procedure or placement of the drainage tube was not successful
  • People who have a medical reason they cannot take standard tuberculosis medications, including any known allergy to these drugs or their ingredients
  • Women who have a positive pregnancy test
  • People with a confirmed autoimmune condition, such as lupus

Additional criteria that apply to a specific heart scan (MRI with contrast dye) part of the trial — people may not be eligible for this part if they:

  • Have any implanted medical devices that are not safe to use near an MRI machine (such as pacemakers, defibrillators, certain brain aneurysm clips, or cochlear implants)
  • Experience severe anxiety in enclosed spaces (claustrophobia)
  • Have a known allergy to the MRI contrast dye (gadolinium)
  • Are unable to lie flat and still for an extended period (for example, due to severe heart failure)
  • Are currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mpiko U Ntsekhe, Professor, Department of Cardiology, Groote Schuur Hospital

Phone: 0727633386

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Cape Town
Registry
ClinicalTrials.gov
Start date
10 January 2022
Est. completion
15 September 2025

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

Drug exposure in PCF and mediates in Mtb load

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov