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Am J Respir Crit Care Med. 2006 Aug 1;174(3):331-8. Epub 2006 May 4.

Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary tuberculosis.

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  • 1Denver Public Health and the Department of Medicine, University of Colorado Health Sciences; National Jewish Medical and Research Center, Denver, Colorado, USA. bburman@dhha.org

Abstract

RATIONALE:

Moxifloxacin has promising preclinical activity against Mycobacterium tuberculosis, but has not been evaluated in multidrug treatment of tuberculosis in humans.

OBJECTIVE:

To compare the impact of moxifloxacin versus ethambutol, both in combination with isoniazid, rifampin, and pyrazinamide, on sputum culture conversion at 2 mo as a measure of the potential sterilizing activity of alternate induction regimens.

METHODS:

Adults with smear-positive pulmonary tuberculosis were randomized in a factorial design to receive moxifloxacin (400 mg) versus ethambutol given 5 d/wk versus 3 d/wk (after 2 wk of daily therapy). All doses were directly observed.

MEASUREMENTS:

The primary endpoint was sputum culture status at 2 mo of treatment.

RESULTS:

Of 336 patients enrolled, 277 (82%) were eligible for the efficacy analysis, 186 (67%) were male, 175 (63%) were enrolled at African sites, 206 (74%) had cavitation on chest radiograph, and 60 (22%) had HIV infection. Two-month cultures were negative in 71% of patients (99 of 139) treated with moxifloxacin versus 71% (98 of 138) treated with ethambutol (p = 0.97). Patients receiving moxifloxacin, however, more often had negative cultures after 4 wk of treatment. Patients treated with moxifloxacin more often reported nausea (22 vs. 9%, p = 0.002), but similar proportions completed study treatment (88 vs. 89%). Dosing frequency had little effect on 2-mo culture status or tolerability of therapy.

CONCLUSIONS:

The addition of moxifloxacin to isoniazid, rifampin, and pyrazinamide did not affect 2-mo sputum culture status but did show increased activity at earlier time points.

PMID:
16675781
[PubMed - indexed for MEDLINE]
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