Comparison of Pulmonary Tuberculosis Treatment Efficacy with Moxifloxacin for 4 Months vs. Standard Treatment of Pulmonary Tuberculosis. Intention-to-Treat Analysis (ITT)

Abstract

Background. The pulmonary tuberculosis (TB) is a global public health problem that is preventable, treatable and eradicable. The Worl Organization reports that almost one‐third of the worlds population is infected with Mycobacterium tuberculosis. Fluoroquinolones have shown promising activity against mycobacteria and have been established as a critical component of the treatment of multi‐resistant tuberculosis. It has been proposed that these drugs may play a role in reducing the duration of treatment. Methods. It is a clinical, double‐blind, randomized and phase 3 trial. The Results from a research center are reported. The study population were adult patients with pulmonary tuberculosis who had not received previous antifimic treatment. Of 30 patients evaluated, 22 met the selection criteria and were randomized: 9 to group 1, 5 to group 2 and 8 to group 3. Treatment Groups: Group 1. 2HRZE/4HR. (standard treatment) for 6 months. Group 2. 2HRZM/2HRM. Replacement of ethambutol with moxifloxacin for 4 months. Group 3. 2RZEM/2RM. Replacement of isoniazid with moxifloxacin for 4 months. H: isoniazid R: rifampicin Z: pyrazinamide E: ethambutol M: moxifloxacin. Results. In the intention‐to‐treat analysis, a favorable outcome was found in 75% in the standard group, 100% in the isoniazid group and 87.5% in the ethambutol group (1 patient had a relapse at 18 months). The patients in the standar group had negative sputum smear microscopy before those in isoniazid group and ethambutol group (6.3, 7.8 and 8.0 weeks respectively). The negative cultures at 8 weeks was also better in the standard group with 75% vs. 60% and 37.5% of isoniazid and the ethambutol groups. Two patients had both serious adverse events from the standard treatment. Seventeen patients in total presented some non‐severe adverse event without significant difference between the groups. Conclusion. the standard regimen and the regimen of isoniazid + moxifloxacin showed a favorable response in all patients treated in the protocol analysis, without relapses, compared with the ethambutol group. The isoniazid group showed no inferiority in its efficacy compared with the standard control and presented better results related to safety.