drugset / Trial / NCT03830671
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
NaSingle-groupOpen-labelTreatment
Summary
WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to deliver effective treatment and care. According to the 2018 WHO TB Report, the overall treatment success rate of MDR-TB is 55% while much lower in China at just only 41% with the 24-month regimen. In order to further verify the safety and efficiency of optimizing shorter 18-month regimen containing 6 anti-TB drugs with MDR-TB patients,500 more patients will be enrolled and observed.
Timeline
- Start
- 2019-03-08
- Primary completion
- 2022-06-08
- Completion
- 2022-06-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amikacin | Small molecule | — | — |
| Subject | Bedaquiline | Small molecule | — | — |
| Subject | Clarithromycin | Small molecule | — | — |
| Subject | Clofazimine | Small molecule | — | — |
| Subject | Cycloserine | Small molecule | — | — |
| Subject | Ethambutol | Small molecule | — | — |
| Subject | Linezolid | Other / unclassified | — | — |
| Subject | Moxifloxacin | Small molecule | — | — |
| Subject | Protionamide | Small molecule | — | — |
| Subject | Pyrazinamide | Small molecule | — | — |
| Subject | sodium para-aminosalicylate | Unknown | — | — |