REMoxTB

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

Major Points

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:

Population

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

Interventions

Outcomes

Primary Outcomes

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading