Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04521803

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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

Not Eligible

You will not qualify if you...

  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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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

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