REMoxTB

Incomplete

Gillespie SH, et al. "Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis". The New England Journal of Medicine. 2014. 371(17):1577-1587.
PubMed • Full text • PDF

Clinical Question

In adults with newly diagnosed pulmonary tuberculosis, can the substitution of moxifloxacin for either isoniazid or ethambutol in a shortened four-month treatment regimen, compared to the standard six-month regimen, treat tuberculosis effectively?

Bottom Line

Four-month tuberculosis regimens containing moxifloxacin are not as effective as the standard six-month regimen.

Guidelines

No guidelines have been published that reflect the results of this trial.

Design

• Multicenter, double-blind, phase 3, randomized, placebo-controlled noninferiority trial
• N=1,931 underwent randomization
  • Isoniazid group (n=655)
  • Ethambutol group (n=636)
  • Control group (n=640)
• Setting: Multicenter study in South Africa, India, Tanzania, Kenya, Thailand, Malaysia, Zambia, China and Mexico
• Study start date: January 2008. Study completion date: February 2014.
• Analysis: Modified intention-to-treat and per-protocol analysis
• Primary outcome: