Can a higher dose of rifampicin clear TB around the heart faster?
NCT ID NCT04521803
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests whether giving a higher dose of the antibiotic rifampicin (35 mg/kg) can increase drug levels in the fluid around the heart and clear tuberculosis bacteria faster than the standard dose (10 mg/kg). The study enrolls adults with suspected tuberculous pericarditis, a TB infection of the sac around the heart, and compares the two doses added to standard TB treatment. Researchers will measure drug exposure in the pericardial fluid and how quickly bacterial cultures turn positive, as well as track mortality and other clinical outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high-dose rifampicin (35 mg/kg) compared to standard-dose rifampicin (10 mg/kg)
- What this could lead to
- If it works, a higher dose of rifampicin could speed up bacterial clearance in the fluid around the heart, potentially reducing complications and improving outcomes for people with tuberculous pericarditis.
- What could go wrong
- This is a small Phase 2 trial, so results may not hold up in larger studies. Higher doses of rifampicin may also increase side effects, such as liver toxicity, and the trial does not yet prove any survival benefit.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
52 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged \>18 years 2. Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole) 3. Consent to study participation including testing for HIV-1 (if HIV status is unknown) 4. 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: 1. Evidence of pericarditis with microbiologic confirmation of Mtb- infection elsewhere in the body and/or 2. Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U/L) 5. Participant will undergo pericardiocentesis (as per clinical indication) 6. Within 5 days of ATT initiation Exclusion Criteria: 1. Glomerular filtration rate \<30ml/min or renal failure requiring dialysis 2. Rifampin-resistant TB 3. Severe concurrent opportunistic infection 4. Contraindication to placement of intra-pericardial catheter 5. Failed pericardiocentesis procedure and/or failure of placement of intra-pericardial catheter 6. 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. 7. In females: a positive urine pregnancy test result 8. Confirmed autoimmune disorders (e.g. systemic lupus erythematosus) Additional Exclusions for Gadolinium contrasted CMR 1. Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.) 2. Claustrophobia 3. Gadolinium allergy 4. Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure) 5. Breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Groote Schuur Hospital
Cape Town, Western Cape, 7925, South Africa
-
Nelson Mandela Academic Hospital
Mthatha, Eastern Cape, 5099, South Africa
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