Recruitment

Recruitment Status
Not yet recruiting

Inclusion Criteria

Participant will undergo pericardiocentesis (as per clinical indication)
Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)
Within 5 days of ATT initiation
...
Participant will undergo pericardiocentesis (as per clinical indication)
Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)
Within 5 days of ATT initiation
Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U/L)
Aged >18 years
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

Exclusion Criteria

Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
Breastfeeding
Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
...
Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
Breastfeeding
Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
Gadolinium allergy
Claustrophobia

Summary

Conditions
  • HIV Status
  • Tuberculous Pericarditis
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Participant identification numbers (PID), assigned at the screening visit, will be used throughout the study. After signing the informed consent document; eligible participants will be stratified by HIV status and then further stratified by GX-Ultra status to ensure equal allocation regardless of HIV status and likely subsequent culture status. An electronic randomization tool will be used to randomize the subgroups in a 1:1 ratio. The randomization list will be generated and updated by the study coordinator, trial pharmacist, or statistician who will have no direct contact with trial participants or involvement with the assessment for eligibility in the trial.Masking: Triple (Participant, Care Provider, Investigator)
  • Masking Description: Neither participants nor the investigators will be aware of the participant's treatment allocation until the end of the study (double blinding). Blinding will be maintained by manufacture of placebo tablets similar in appearance and packaging to that of the study drug, with centralized dispensing by the study pharmacist. Unmasking procedures are detailed by SOP.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

IMPI-3 - A Randomized Controlled Trial of High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis Phase 2b Randomized, placebo-controlled, double-blinded clinical trial The trial will enroll 100 adult participants with pericardial TB from two research sites in South Africa, with no e...

IMPI-3 - A Randomized Controlled Trial of High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis Phase 2b Randomized, placebo-controlled, double-blinded clinical trial The trial will enroll 100 adult participants with pericardial TB from two research sites in South Africa, with no exclusions being made on the basis of sex/gender, racial or ethnic group. Consenting participants will be stratified by HIV status and PCF GX-Ultra status, then randomized 1:1 to receive either standard of care anti-tuberculosis treatment (ATT) or standard of care plus high dose Rifampicin (RIF), both administered orally for 2 months, followed by a continuation phase of 4 months' RH at standard doses.

Inclusion Criteria

Participant will undergo pericardiocentesis (as per clinical indication)
Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)
Within 5 days of ATT initiation
...
Participant will undergo pericardiocentesis (as per clinical indication)
Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)
Within 5 days of ATT initiation
Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U/L)
Aged >18 years
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

Exclusion Criteria

Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
Breastfeeding
Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
...
Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
Breastfeeding
Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
Gadolinium allergy
Claustrophobia

Tracking Information

NCT #
NCT04521803
Collaborators
Not Provided
Investigators
  • Principal Investigator: Mpiko U Ntsekhe, Professor Department of Cardiology, Groote Schuur Hospital Principal Investigator: Robert J Wilkinson, Professor Wellcome Centre for Infectious Diseases Research in Africa, University of Cape Town
  • Mpiko U Ntsekhe, Professor Department of Cardiology, Groote Schuur Hospital Principal Investigator: Robert J Wilkinson, Professor Wellcome Centre for Infectious Diseases Research in Africa, University of Cape Town