Phase
Condition
Cardiovascular Disease
Heart Disease
Cardiac Disease
Treatment
high dose Rifampicin (RIF)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged >18 years
Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echofree space of ≥1 cm anterior to the right ventricle in diastole)
Consent to study participation including testing for HIV-1 (if HIV status isunknown)
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 perMayosi et al.4:
Evidence of pericarditis with microbiologic confirmation of Mtb- infectionelsewhere 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
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-pericardialcatheter
Any disease or condition in which the use of the standard anti-TB drugs (or any oftheir components) are contraindicated. This includes, but is not limited to, allergyto 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. severecongestive cardiac failure)
Breastfeeding
Study Design
Study Description
Connect with a study center
Nelson Mandela Academic Hospital
Mthatha, Eastern Cape 5099
South AfricaSite Not Available
Groote Schuur Hospital
Cape Town, Western Cape 7925
South AfricaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.