Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With … (NCT05382312) | Clinical Trial Compass
CompletedPhase 2
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
South Africa127 participantsStarted 2022-07-26
Plain-language summary
This study aims to measure the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics with GSK3036656 in combination with either delamanid or bedaquiline or BTZ-043, delamanid in combination with bedaquiline or standard of care for 14 days in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants will revert to the standard treatment (RIFAFOUR® e-275) once the study treatment (Day 1 to Day 14) has been completed.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. New episode of untreated, rifampicin-susceptible pulmonary tuberculosis (TB)
✓. A chest X-ray picture consistent with pulmonary TB
✓. At least one sputum sample positive on direct microscopy for acid-fast bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease \[IUATLD\]/World Health Organization \[WHO\] scale) or positive on a molecular test (at least medium positive for MTB on Xpert MTB/Rif)
✓. Normal echocardiogram or echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation is allowed and no valvular stenosis.
✓. A creatinine clearance greater than or equal to (\>=)90 mL/minute (Cockroft-Gault formula).
Exclusion criteria
✕. having a cluster of differentiation (CD)4+ count \<350 cells/microliters;
✕. having received any antiretroviral therapy medication within the last 30 days;
✕. or having received oral or intravenous antifungal medication within the last 30 days;
What they're measuring
1
Change from Baseline in log10 CFU of Mycobacterium tuberculosis (MTB) (per milliliters of respiratory sputum samples)
✕. or with an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection or malignancies in the last 12 months (except pulmonary TB).