Early Bactericidal activity (EBA) of Rifampicin and Faropenem in Tuberculosis(Rifampicin Susceptible )
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The primary outcome of EBA will be 7 days measured by the daily rate of change of log10CFU in sputum (EBACFU0–7). The slopes can be described by linear, bilinear, or multiple regression depending on which method fits the data best. Secondary endpoints include the EBACFU days 0–2, EBACFU days 2–7, EBACFU days 0–7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.
研究概览
简要总结
The current study is proposed to design an efficient, all oral, shorter regimen for TB treatment. The innovation driving our approach is the synergistic activity anti-tuberculosis activity observed between rifampicin and certain beta-lactam antibiotics and between certain classes of beta-lactam themselves. Different groups have demonstrated clinically relevant inhibition of MTB in the presence of penems and cephalosporins used alone or in combination with Rifampicin and Ethambutol. The proven safety of Penems,their bioavailability along with the proven anti-mycobacterial activity and synergism with Rifampicin,makes the proposal promising.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical suspicion of pulmonary TB: persistent productive cough for ≥ 2 weeks Patient volunteers to give 2 sputum specimens over the course Age 18 years and above Willing and able to give valid informed written consent Patients free from any other disease or infection of lung such as Sarcoidosis COPD Lung Cancer etc.
排除标准
- •Known hypersensitivity to anti-TB drugs Patients with extra-pulmonary TB Patients with any other chronic pulmonary diseases Presence of secondary immunodeficiency states; organ transplantation diabetes mellitus malignancy treatment with corticosteroids Pregnancy and lactation Patients unlikely to comply with the treatment regimen.
结局指标
主要结局
The primary outcome of EBA will be 7 days measured by the daily rate of change of log10CFU in sputum (EBACFU0–7). The slopes can be described by linear, bilinear, or multiple regression depending on which method fits the data best. Secondary endpoints include the EBACFU days 0–2, EBACFU days 2–7, EBACFU days 0–7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.
时间窗: The primary efficacy endpoint will be | 1. the EBA over 7 days measured by the daily rate of change of log10CFU in sputum (EBACFU0–7). | The slopes can be described by linear, bilinear, or multiple regression depending on which method fits the data best. 2.Secondary endpoints include the EBACFU days 0–2, EBACFU days 2–7, EBACFU days 0–7. | 3.EBA TTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.
次要结局
- Secondary endpoints include the EBACFU days 0–2, EBACFU days 2–7, EBACFU days 0–7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.