Efficacy of ultra-short course chemotherapy for new smear positive drug susceptible pulmonary tuberculosis: study protocol of a multicenter randomized controlled clinical trial
نویسندگان
چکیده
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 .
منابع مشابه
Effects of Ziziphus jujuba on the Prevention of Drug Induced Liver Enzyme Disorders in Pulmonary Tuberculosis Patients: Protocol for Randomized controlled trial
Liver damage is the most common complication of anti-tuberculosis drugs, but there is currently no standard prevention for it. The main purpose of this study is to determine the effectiveness of Ziziphus jujuba (Z. jujuba) syrup on the prevention of liver enzyme disorder in TB patients. This study was a protocol for randomized controlled trial. 48 patients were included in the study who were r...
متن کاملLevamisole as an Adjuvant to Short-Course Therapy in Newly Diagnosed Pulmonary Tuberculosis Patients
BACKGROUND The estimated incidence and prevalence of tuberculosis in India are 2.1 and 2.6 million cases respectively. Immunotherapy may shorten tuberculosis treatments and improve the immunity of individuals as well. Hence we study the efficacy of levamisole (LVM) (immunomodulator) as an adjuvant to chemotherapy of pulmonary tuberculosis patients. MATERIALS AND METHODS A randomized, double-b...
متن کاملEvaluation of Hepatoprotective Effect of Silymarin Among Under Treatment Tuberculosis Patients: A Randomized Clinical Trial
Hepatic toxicity is the most serious adverse effect of anti tuberculosis drugs. This study was performed to evaluate efficacy of silymarin as a hepatoprotective herbal agent. In a randomized double blind clinical trial 70 new cases of pulmonary tuberculosis were divided into two groups. The intervention group was assigned to receive silymarin and the control group received placebo. Tuberculosis...
متن کاملEvaluation of Hepatoprotective Effect of Silymarin Among Under Treatment Tuberculosis Patients: A Randomized Clinical Trial
Hepatic toxicity is the most serious adverse effect of anti tuberculosis drugs. This study was performed to evaluate efficacy of silymarin as a hepatoprotective herbal agent. In a randomized double blind clinical trial 70 new cases of pulmonary tuberculosis were divided into two groups. The intervention group was assigned to receive silymarin and the control group received placebo. Tuberculosis...
متن کاملEffect of Poor Glycemic Control in Newly Diagnosed Patients with Smear-Positive Pulmonary Tuberculosis and Type-2 Diabetes Mellitus
Background: There is growing evidence that diabetes mellitus (DM) is an important risk factor for tuberculosis (TB). A significant number of DM patients have poor glycemic control. This study was carried out to find the impact of poor glycemic control on newly diagnosed smear-positive pulmonary tuberculosis patients with type-2 diabetes mellitus in a tertiary care hospital.Methods: In a hospita...
متن کامل