High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
Recruiting
Phase 2Interventional Study
Tuberculous PericarditisHIV Status
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
University of Cape Town · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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
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