NCT04521803CompletedPhase 2
High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
IMPI-3 - A Randomized Controlled Trial of High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 16 Jul 2020
- Start date
- 10 Jan 2022
- Primary completion date
- 26 Mar 2026
- Lead sponsor
- University of Cape Town
- Diseases
- HIV
- NCT number
- NCT04521803
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 52
- From 10 Jan 2022 to the primary completion date, 26 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concurrent opportunistic infection
- Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
Other illness
- Glomerular filtration rate \<30ml/min or renal failure requiring dialysis
- 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.
- Confirmed autoimmune disorders (e.g. systemic lupus erythematosus)
- Additional Exclusions for Gadolinium contrasted CMR
- Gadolinium allergy
- Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
Other
- Rifampin-resistant TB
- Contraindication to placement of intra-pericardial catheter
- In females: a positive urine pregnancy test result
- Claustrophobia
- Breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Groote Schuur Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Nelson Mandela Academic Hospital Coordinator of this site? Confirm its status | Mthatha | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.