Status:
RECRUITING
High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
Lead Sponsor:
University of Cape Town
Conditions:
Tuberculous Pericarditis
HIV Status
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators hypothesise that high dose RIF (RIF35) will increase pericardial fluid RIF exposure and so enhance mycobacterial clearance, compared to standard of care dosing (RIF10). This Phase 2...
Detailed Description
IMPI-3 - A Randomized Controlled Trial of High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis Phase 2b Randomized, placebo-controlled, double-blinded clinical trial The trial wil...
Eligibility Criteria
Inclusion
- Aged \>18 years
- Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)
- Consent to study participation including testing for HIV-1 (if HIV status is unknown)
- 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:
- Evidence of pericarditis with microbiologic confirmation of Mtb- infection elsewhere in the body and/or
- Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U/L)
- Participant will undergo pericardiocentesis (as per clinical indication)
- Within 5 days of ATT initiation
Exclusion
- Glomerular filtration rate \<30ml/min or renal failure requiring dialysis
- Rifampin-resistant TB
- Severe concurrent opportunistic infection
- Contraindication to placement of intra-pericardial catheter
- Failed pericardiocentesis procedure and/or failure of placement of intra-pericardial catheter
- 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.
- In females: a positive urine pregnancy test result
- Confirmed autoimmune disorders (e.g. systemic lupus erythematosus)
- Additional Exclusions for Gadolinium contrasted CMR
- Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
- Claustrophobia
- Gadolinium allergy
- Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
- Breastfeeding
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04521803
Start Date
January 10 2022
End Date
February 28 2026
Last Update
August 21 2025
Active Locations (2)
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1
Nelson Mandela Academic Hospital
Mthatha, Eastern Cape, South Africa, 5099
2
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925