A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis
Abstract Background: Moxifloxacin (MFX, M) is currently a second-line antituberculosis drug as initial therapy of pulmonary tuberculosis and one of the main anti-TB drugs in drug-resistant TB, which can kill both intracellular and extracellular Mycobacterium tuberculosis. We started a trial to study the efficacy and safety of the substitution of pyrazinamide and ethambutol with moxifloxacin during the intensive phase of treatment of newly diagnosed susceptive pulmonary tuberculosis. Methods/design: This is a prospective, open, randomized, parallel-controlled, single-center clinical study. The study consists of three phases: a screening period, a treatment period of 6 (or 7) months, and a follow-up period of 1 year. Patients selected for the study will be allocated to the trial group or the control group randomly. The control group will be given six months of a standard regimen(2HRZE/4HR). The trial group will be given a total of six months of treatment with substitution of pyrazinamide and ethambutol with moxifloxacin during the intensive phase(2HRM/4HR). The primary outcome is the rate of adverse outcomes within one year of completion of therapy. The Secondary outcomes include the rate of treatment success at the 2nd, 3rd, 5th and 6th months, the rate of sputum Mtb(Mycobacterium tuberculosis) negative conversion at the 2nd, 3rd, 5th and 6th months, the time of sputum Mtb negative conversion at the 2nd, 3rd, 5th and 6th months, and the number of patients with adverse events within one year of completion of therapy. Comparisons will be performed using two-sided tests with a statistical significance level of 5%.Discussion: This trial will reveal the effectiveness and safety of 2months of use of moxifloxacin instead of pyrazinamide and ethambutol during the intensive phase of treatment for newly diagnosed susceptive pulmonary tuberculosis. If the new regimen including isoniazid, rifampicin and moxifloxacin during the intensive phase of treatment (2HRM/4HR) is no less effective and safe than the standard regimen(2HRZE/4HR), it could be a new alternative treatment for newly diagnosed susceptive pulmonary tuberculosis in the future. Trial registration: ClinicalTrials.gov, NCT04187469. Registered on 5 December 2019.