Substitution of Moxifloxacin for Isoniazid during intensive phase treatment of Pulmonary Tuberculosis.
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Date
2009
Journal Title
Journal ISSN
Volume Title
Publisher
American Thoracic Society.
Abstract
Rationale: Moxifloxacin has potent activity against Mycobacterium tuberculosis in vitro and in a mouse model of antituberculosis (TB) chemotherapy, but data regarding its activity in humans are limited. Objectives: Our objective was to compare the antimicrobial activity and safety of moxifloxacin versus isoniazid during the first 8 weeks of
combination therapy for pulmonary TB. Methods: Adults with sputum smear–positive pulmonary TB were randomly assigned to receive either moxifloxacin 400 mg plus isoniazid placebo, or isoniazid 300 mg plus moxifloxacin placebo,
administered 5 days/week for 8 weeks, in addition to rifampin, pyrazinamide, and ethambutol. All doses were directly observed. Sputum was collected for culture every 2 weeks. The primary outcome was negative sputum culture at completion of 8 weeks of treatment. Measurements and Main Results: Of 433 participants enrolled, 328 were eligible for the primary efficacy analysis. Of these, 35 (11%) were HIV positive, 248 (76%) had cavitation on baseline chest
radiograph, and 213 (65%) were enrolled at African sites. Negative cultures at Week 8 were observed in 90/164 (54.9%) participants in the isoniazid arm, and 99/164 (60.4%) in the moxifloxacin arm (P=0.37). In multivariate analysis, cavitation and enrollment at an African site were associated with lower likelihood of Week-8 culture
negativity. The proportion of participants who discontinued assigned treatment was 31/214 (14.5%) for the moxifloxacin group versus 22/205 (10.7%) for the isoniazid group (RR, 1.35; 95% CI, 0.81, 2.25).Conclusions: Substitution of moxifloxacin for isoniazid resulted in a small but statistically nonsignificant increase in Week-8 culture
negativity.
Description
Keywords
Tuberculosis, Pulmonary--Drug therapy., Tuberculosis, Pulmonary--Treatment., Antitubercular agents., HIV infections--Complications.
Citation
Dorman, S.E., et al. 2009. Substitution of Moxifloxacin for Isoniazid during intensive phase treatment of Pulmonary Tuberculosis. American Journal of Respiratory and Critical Care Medicine 180 (3) pp. 273-280.