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, 17 (1), 435

Efficacy of Ultra-Short Course Chemotherapy for New Smear Positive Drug Susceptible Pulmonary Tuberculosis: Study Protocol of a Multicenter Randomized Controlled Clinical Trial

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Efficacy of Ultra-Short Course Chemotherapy for New Smear Positive Drug Susceptible Pulmonary Tuberculosis: Study Protocol of a Multicenter Randomized Controlled Clinical Trial

Mengqiu Gao et al. BMC Infect Dis.

Abstract

Background: 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.

Methods: We 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 registration: The protocol has been registered on ClinicalTrials.gov on 2 September,2016 with identifier NCT02901288 .

Keywords: Clinical trial; Drug susceptible pulmonary tuberculosis; Short course chemotherapy.

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