Abstract
BackgroundShortening the standard 6-month treatment for drug-susceptible pulmonary tuberculosis (DS-PTB) would be a major improvement for TB case management and disease control. MethodsWe are conducting a randomized, open-label, controlled, non-inferiority trial involving patients with smear-positive, newly diagnosed DS-PTB cases nationwide to assess the efficacy and safety of two 4.5- month regimens in comparison to the standard 6-month WHO recommended regimen. The regimen used in one experiment group is a 4.5-month fluoroquinolone-containing regimen, which consists of full course of levofloxacin, isoniazid (H), rifampin (R), parazinamid (Z) and ethambutol (E). Regimen used in the second experiment group includes 4.5-month full course of H, R, Z, E with levofloxacin removed. Patients in the control group, receive H, R, Z and E for 2 months, followed by 4 months of H and R. The primary endpoint is treatment failure or relapse within 24 month after treatment completion.Discussion Results from this trial along with other studies will contribute to the science of constructing a shorter, effective and safe regiment for TB patients.Trial registrationThe protocol has been registered on ClinicalTrials.gov on 2 September,2016 with identifier NCT02901288.
Highlights
Shortening the standard 6-month treatment for drug-susceptible pulmonary tuberculosis (DS-PTB) would be a major improvement for TB case management and disease control
The first pharmacodynamic data showed that levofloxacin(Lfx) was less effective than moxifloxacin(Mfx) and Gfx
Other studies have shown that Mfx and Gfx are better than ofloxacin, but do not contain comparison with Lfx [11]
Summary
Shortening the standard 6-month treatment for drug-susceptible pulmonary tuberculosis (DS-PTB) would be a major improvement for TB case management and disease control. In 2014, 3 independent clinical trials named REMoxTB, RIFAQUIN and OFLOTUB/Gatifloxacin (Gfx) simultaneously reported final results of shortening treatment duration for DS-PTB by using FQ-based regimens [7,8,9]. Noninferiority for these regimens was not shown as compared to the standard 6-month regimen, indicating that shortening treatment to 4 months was not effective in these settings. Given the strong bactericidal and sterilizing activities of H, R, E and Z, parallel treatment shortening trial is in progress with the consideration of increasing drug combination at continuation phase as compared with the standard 6-month regimen
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