High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
Recruiting · NCT04521803 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Cape Town
View the official record on ClinicalTrials.gov →Interventions studied
high dose Rifampicin (RIF)
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed.
- Nelson Mandela Academic Hospital - Mthatha, Eastern Cape, South Africa
- Groote Schuur Hospital - Cape Town, Western Cape, South Africa