Abstract
Background Tuberculosis (TB) remains a major killer amongst infectious diseases. Current treatment involves a four-drug regimen for at least six months. New drugs and regimens are required to shorten treatment duration, reduce toxicity and combat drug resistance however the optimal methodology to define the critical path for these regimens is not well-defined. We undertook a literature review to summarise outcomes reported in phase II trials of patients with newlydiagnosed pulmonary TB to determine the necessity for a core outcome set in TB.
Highlights
Tuberculosis (TB) remains a major killer amongst infectious diseases
We undertook a literature review to summarise outcomes reported in phase II trials of patients with newlydiagnosed pulmonary TB to determine the necessity for a core outcome set in TB
The majority of studies defined early bactericidal activity (EBA) as the fall in log10 colony forming units (CFU) per ml sputum over various time points. Related outcomes such as CFU count were sometimes reported in preference (12 studies)
Summary
Tuberculosis (TB) remains a major killer amongst infectious diseases. Current treatment involves a four-drug regimen for at least six months. Reported outcomes in phase II studies of newly-diagnosed pulmonary tuberculosis From The 4th Meeting of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative Rome, Italy. Background Tuberculosis (TB) remains a major killer amongst infectious diseases.
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