High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cape Town
About this trial
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.
Eligibility criteria
Qualifiers
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)
Evidence of pericarditis with microbiologic confirmation of Mtb- infection elsewhere in the body and/or
Disqualifiers
Glomerular filtration rate <30ml/min or renal failure requiring dialysis
Rifampin-resistant TB
Severe concurrent opportunistic infection
Contraindication to placement of intra-pericardial catheter
Trial design
Treatments tested in this trial
- high dose Rifampicin (RIF)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov