High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis

Launched by UNIVERSITY OF CAPE TOWN · Aug 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different doses of a medication called Rifampicin (RIF) for treating a condition known as Effusive Tuberculous Pericarditis (PCTB), which is an infection of the heart lining caused by tuberculosis. The researchers want to find out if a higher dose of Rifampicin (35 mg/kg) is more effective at helping the body clear the infection compared to the standard lower dose (10 mg/kg). The trial will involve participants who are 18 years or older, have a confirmed diagnosis of PCTB, and are starting treatment for tuberculosis. Participants will undergo a procedure to remove excess fluid around the heart and will be monitored for safety and effectiveness throughout the study.

To take part in this trial, participants need to be healthy enough for the study and not have certain medical conditions that could complicate their treatment. For example, people with severe kidney problems or those who are pregnant cannot join. If eligible, participants will receive either the higher or standard dose of Rifampicin, and they will not know which one they are getting to ensure the study is fair. This trial aims to improve treatment options for PCTB, and it is currently recruiting participants. If you or a loved one are considering joining, it's essential to discuss it with your healthcare provider to understand all the details and make an informed decision.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged \>18 years
• • 2. Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)
• • 3. Consent to study participation including testing for HIV-1 (if HIV status is unknown)
• 4. Microbiologically detected Mtb in PCF or diagnosis of probable PCTB. Probable PCTB (in the absence of a positive pericardial fluid culture) will be defined as per Mayosi et al.4:
• • 1. Evidence of pericarditis with microbiologic confirmation of Mtb- infection elsewhere in the body and/or
• • 2. Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U/L)
• • 5. Participant will undergo pericardiocentesis (as per clinical indication)
• • 6. Within 5 days of ATT initiation
• Exclusion Criteria:
• • 1. Glomerular filtration rate \<30ml/min or renal failure requiring dialysis
• • 2. Rifampin-resistant TB
• • 3. Severe concurrent opportunistic infection
• • 4. Contraindication to placement of intra-pericardial catheter
• • 5. Failed pericardiocentesis procedure and/or failure of placement of intra-pericardial catheter
• • 6. Any disease or condition in which the use of the standard anti-TB drugs (or any of their components) are contraindicated. This includes, but is not limited to, allergy to any TB drug or their components.
• • 7. In females: a positive urine pregnancy test result
• • 8. Confirmed autoimmune disorders (e.g. systemic lupus erythematosus)
• • Additional Exclusions for Gadolinium contrasted CMR
• • 1. Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
• • 2. Claustrophobia
• • 3. Gadolinium allergy
• • 4. Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
• • 5. Breastfeeding