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Published ahead of print on May 4, 2006, doi:10.1164/rccm.200603-360OC

Am. J. Respir. Crit. Care Med., Volume 174, Number 3, August 2006, 331-338

A more recent version of this article appeared on August 1, 2006
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Submitted on March 11, 2006
Accepted on May 1, 2006

Moxifloxacin versus Ethambutol in the First Two Months of Treatment for Pulmonary Tuberculosis

William J Burman1*, Stefan Goldberg2, John L Johnson3, Grace Muzanye3, Melissa Engle4, Ann W Mosher5, Shurjeel Choudhri6, Charles L Daley7, Sonal S Munsiff8, Zhen Zhao2, Andrew Vernon2, and Richard E Chaisson9

1 Denver Public Health and Department of Medicine, University of Colorado Health Sciences, Denver, CO, USA, 2 Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA, 3 Department of Medicine, Division of Infectious Diseases, Case Western Reserve University, Cleveland, OH, USA; University Hospitals of Cleveland, Cleveland, OH, USA; Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda, 4 South Texas Veterans Health Care System, San Antonio, TX, USA, 5 Duke University Medical Center, Durham, NC, USA, 6 Bayer, Inc, Toronto, Ontario, Canada, 7 National Jewish Medical and Research Center, Denver, CO, USA, 8 Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA; New York City Department of Health and Mental Hygiene, New York City, NY, USA, 9 Johns Hopkins University Center for TB Research, Baltimore, MD, USA

* To whom correspondence should be addressed. E-mail: BBurman{at}dhha.org.

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 vs. ethambutol, both in combination with isoniazid, rifampin and pyrazinamide, on sputum culture conversion at 2 months 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) vs. ethambutol given 5 days/week vs. 3 days/week (after 2 weeks of daily therapy). All doses were directly observed. Measurements: The primary endpoint was sputum culture status at 2 months 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 vs. 71% (98 of 138) treated with ethambutol (p = 0.97). However, patients receiving moxifloxacin more often had negative cultures after 4 weeks 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-month culture status or tolerability of therapy. Conclusions: The addition of moxifloxacin to isoniazid, rifampin, and pyrazinamide did not affect 2-month sputum culture status, but did show increased activity at earlier time points. www.clinicaltrials.gov Identifier: NCT00140309
Key words: tuberculosis, moxifloxacin, efficacy, toxicity, randomized trial




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