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Randomized Controlled Trial
. 2013 Oct 1;188(7):858-64.
doi: 10.1164/rccm.201303-0604OC.

Comparison of levofloxacin versus moxifloxacin for multidrug-resistant tuberculosis

Affiliations
Randomized Controlled Trial

Comparison of levofloxacin versus moxifloxacin for multidrug-resistant tuberculosis

Won-Jung Koh et al. Am J Respir Crit Care Med. .

Abstract

Rationale: Levofloxacin (LFX) and moxifloxacin (MXF) are the two most frequently recommended fluoroquinolones for treatment of patients with multidrug-resistant tuberculosis (MDR-TB). However, studies comparing the effectiveness of LFX and MXF among patients with MDR-TB are lacking.

Objectives: To compare the effectiveness of LFX and MXF in terms of culture conversion after 3 months of treatment for MDR-TB.

Methods: In this prospective multicenter randomized open label trial, we randomly assigned 182 patients with MDR-TB (sensitive to LFX and MXF) to receive either LFX (750 mg/day; 90 patients) or MXF (400 mg/day; 92 patients) with a background drug regimen. The primary outcome was the proportion of patients who achieved sputum culture conversion at 3 months of treatment. Secondary outcomes were time to culture conversion and time to smear conversion, with data censored at 3 months, and the proportions of adverse drug reactions.

Measurements and main results: At 3 months of treatment, 68 (88.3%) of the 77 patients in the LFX group and 67 (90.5%) of the 74 in the MXF group showed conversion to negative sputum cultures (odds ratio for LFX compared with MXF, 0.78; 95% confidence interval, 0.27-2.20). Adverse drug reactions were reported in six patients (7.7%) in the LFX group and four (5.2%) in the MXF group (P = 0.75).

Conclusions: The choice of LFX or MXF for treatment of patients with MDR-TB may not affect sputum culture conversion at 3 months of treatment. Clinical trial registered with www.clinicaltrials.gov (NCT 01055145).

Trial registration: ClinicalTrials.gov NCT01055145.

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