Actively Recruiting
High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
Led by University of Cape Town · Updated on 2025-08-21
60
Participants Needed
2
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 2b randomized, placebo-controlled, double-blinded trial will evaluate the efficacy and safety of RIF 35mg/kg compared 10mg/kg, added to standard first-line ATT, for the treatment of PCTB.
CONDITIONS
Official Title
High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nelson Mandela Academic Hospital
Mthatha, Eastern Cape, South Africa, 5099
Not Yet Recruiting
2
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925
Actively Recruiting
Research Team
M
Mpumi U Maxebengula, BCom
CONTACT
K
Kishal Maxebengula, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here