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Clinical Trials Update
December 24/31, 2014

TB Regimens: Less Is Not More

JAMA. 2014;312(24):2609. doi:10.1001/jama.2014.15967

For 3 decades, standard treatment for tuberculosis has consisted of a complex 6-month regimen. Recent experiments with mouse models and promising phase 2 trials, however, seemed to indicate efficacy using shorter and simpler therapeutic regimens. Disappointingly, three phase 3 trials testing a shorter duration treatment including a fluoroquinolone failed to demonstrate noninferiority to standard treatment.

In one phase 3 trial, 1836 patients from sub-Saharan Africa were randomly assigned to receive a standard 6-month regimen for rifampin-sensitive tuberculosis or an experimental 4-month regimen that substituted gatifloxacin for ethambutol during a 2-month intensive phase and continued for another 2 months with isoniazid and rifampin (Merle CS et al. N Engl J Med. doi:10.1056/NEJMoa1315817 [published online October 23, 2014]).

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