Ganfeborole (GSK 3036656)

Submitted by barbara on

July 27, 2022:  Phase 2 began. Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in Combination With Delamanid or Bedaquiline, Delamanid in Combination With Bedaquiline, or Standard of Care in Male and Female Participants Aged 18 to 65 Years With Pulmonary Tuberculosis. https://clinicaltrials.gov/study/NCT05382312  Estimated completion date: September 22, 2023

TB-PRACTECAL

Submitted by barbara on

This is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multidrug-resistant TB (MDR-TB).

MSF Press Release 24 March 2021: https://www.msf.org/drug-resistant-tuberculosis-trial-ends-enrolment-after-positive-initial-data

NexGen EBA

Submitted by barbara on

Early bactericidal activity (EBA), which measures decline in serial sputum colony forming unit (CFU) counts over the first 2-14 days of treatment, has been used extensively as a means of initially evaluating the potency of individual or combinations of antituberculous agents. This approach is endorsed by the Global Alliance for TB Drug Development and the US FDA. However, EBA seems to correlate poorly with the relative ability of an agent to prevent relapse and produce a durable cure (often referred to as sterilizing activity ).

RIFASHORT

Submitted by barbara on

An open-label 3-arm trial to compare a standard 6-month control regimen with two 4-month treatment regimens for the treatment of tuberculosis (TB).

Disease/patients studied The trial will include 820 patients newly diagnosed with pulmonary TB with sputum positive or negative for TB on microscopy but with a positive result on a GeneXpert Test with organisms fully sensitive to rifampicin

Patients enrolled in the trial will be randomly allocated to receive one of the following three chemotherapy treatment regimens:

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