RecruitingPhase 2NCT04521803

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

Sponsor

University of Cape Town

Enrollment

60 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

Tuberculous Pericarditis HIV Status

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a higher dose of rifampicin (an antibiotic) to the standard dose in people with tuberculosis that has infected the lining around the heart (tuberculous pericarditis), to see if the higher dose leads to better outcomes. **You may be eligible if...** - You are older than 18 years - You have fluid around your heart confirmed on ultrasound (echocardiogram) - You have been diagnosed with or are strongly suspected to have tuberculosis of the pericardium (the sac surrounding the heart) - You consent to HIV testing if your status is unknown **You may NOT be eligible if...** - You have conditions that make rifampicin unsafe, such as severe liver disease - You are allergic to rifampicin - You are already being treated for active TB with different medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGhigh dose Rifampicin (RIF)

Simulations were performed to determine the dose of RIF required to achieve the most equitable drug exposures across the weight range, 30 to 100 kg. Demographic data of a reference cohort of TB patients (n = 1225), with or without HIV-1 coinfection, recruited in clinical trials conducted in West Africa and South Africa were used for the simulations35-38. An additional 12 250 virtual patients were generated using the weight and height distributions of the 1225 patients to increase the number of patients with a weight close to the boundaries of the weight range. Parameter estimates of the population PK model for RIF were used to simulate (100 replicates) RIF exposures22. Four dosing scenarios were evaluated using the weight-band based dosing with 4-drug FDC tablets and extra RIF tablets with each tablet containing 150 mg or 600 mg RIF. The FDC tablets were assumed to have 20% reduced bioavailability based on data from a clinical trial where the same formulation was used

Locations(2)

Nelson Mandela Academic Hospital

Mthatha, Eastern Cape, South Africa

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

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NCT04521803