Randomized, Placebo-controlled Study of Safety and Therapeutic Efficacy of the Drug FS-1 in the Oral Dosage Form in Drug-resistant Pulmonary Tuberculosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 6
- 主要终点
- Proportion of Patients with persistently negative sputum cultures (SCC)
研究概览
简要总结
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with the high burden of tuberculosis, the Government of the Republic of Kazakhstan has founded initiative on the development of new Anti-TB drug to treat drug-resistant forms of this infectious disease. JSC "Scientific Center for Anti-infectious Drugs" has developed original drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).
详细描述
Phase 3 clinical study of FS-1 drug is a randomized, interventional, multicenter, placebo-controlled (add-on), double-blind and two arms trial.
The study consists of two following phases: treatment phase - 6 months and follow-up phase 12 months. It is planned to recruit 480 patients with verified MDR-TB diagnosis.
All data will be compiled in an Electronic Data Capture System with further statistical analysis according to approved Statistical Analytical Plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects suffering from a multidrug-resistant form of pulmonary tuberculosis which is defined by:
- •MDR Tuberculosis confirmed by microbiology test at screening.
- •resistance to isoniazid and rifampicin demonstrated by drug susceptibility test
- •susceptiblity of TB bacteria to fluoroquinolones and aminoglycoside/capreomycin
- •all ethnicities, intellectually capable of understanding their own condition and the requirements of the study protocol
- •Willing to freely and voluntarily give signed informed consent
- •Willing and capable to comply with all requirements of the protocol
排除标准
- •Pregnancy and breast-feeding;
- •Patients with decompensated concomitant diseases (cardiovascular, renal, hepatic failure) that may affect the conduct of the study;
- •Severe mental disorders;
- •Allergy to iodine-containing drugs, hypersensitivity to iodine;
- •Intolerance to second-line drugs;
- •Epidermomycosis
- •Socially maladjusted patients suffering from alcoholism and drug addiction;
- •Hypothyroidism;
- •Hashimoto's thyroiditis;
- •TB treatment for more than two months before the start of the study;
- •Not willing to adhere to TB therapy;
- •Exclusion Criteria during the study:
- •at the discretion of the researcher, if the continuation of the study is harmful to the patient;
- •side effects related with the study drug
- •patient's decision to stop participation in study
- •appearance of any exclusion criteria during study
研究组 & 干预措施
A
Standard TB treatment+ treatment regiment with FS-1 drug. Study drug was given to the patients orally once per day in dose of 2.5 mg/kg along with other prescribed TB drugs.
干预措施: FS-1 (Drug)
B
Standard TB treatment + treatment regiment with a placebo. Instead of study drug the placebo was given to the patients orally once per day along with other prescribed TB drugs (in quntity equal to study drug).
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients with persistently negative sputum cultures (SCC)
时间窗: 12 months
Sputum culture conversion (SCC) is a persistently negative result of the sputum culture at one year from the patients who had sputum samples positive for growth of M. tuberculosis at baseline and not followed by any positive culture until the end of the trial. SCC corresponds to the outcome "cured" if at least 5 negative bacteriological cultures is recorded (on solid medium) during 12 months with an interval of at least 30 days.
Time to persistently negative sputum cultures
时间窗: 18 months
Time from the start of treatment with study drug to the first negative M. tuberculosis sputum culture on solid medium followed by 4 consecutive negative results with an interval of at least 30 days. Measured in months. Estimated population: randomized subjects who took at least 70% of planned study drug doses; having a positive bacterial culture M. tuberculosis at the baseline; who missed less than 2 consecutive visits or less than 14 consecutive days of study drug treatment (modified ITT analysis).
次要结局
- The proportion of subjects with relapse of tuberculosis(12 months)
- The incidence and severity of Adverse Events, Serious Adverse Events and drug related Adverse Drug Reactions(18 months)
- Assessment of the study drug effect on thyroid gland function(18 months)
- The median time to occurrence of negative sputum microscopy result(18 months)
- Dynamics of the tuberculosis process based on subjects chest x-ray diagnosis.(18 months)
- Patients body weight dynamics for the period of 18 months.(18 months)
- The time when TB clinical symptoms not observed(18 months)