The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
Summary
Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
Timeline
- Start
- 2016-03
- Primary completion
- 2022-05-13
- Completion
- 2023-05-02
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Clofazimine | Small molecule | 50 mg | Oral |
| Subject | Clofazimine | Small molecule | 100 mg | Oral |
| Subject | Ethambutol | Small molecule | 800 mg | Oral |
| Subject | Ethambutol | Small molecule | 1200 mg | Oral |
| Subject | Isoniazid | Small molecule | 300 mg | Oral |
| Subject | Isoniazid | Small molecule | 400 mg | Oral |
| Subject | Isoniazid | Small molecule | 500 mg | Oral |
| Subject | Isoniazid | Small molecule | 600 mg | Oral |
| Subject | Isoniazid | Small molecule | 800 mg | Oral |
| Subject | Isoniazid | Small molecule | 900 mg | Oral |
| Subject | Kanamycin | Small molecule | 15 mg/kg | — |
| Subject | Levofloxacin | Small molecule | 750 mg | Oral |
| Subject | Levofloxacin | Small molecule | 1000 mg | Oral |
| Comparator | Moxifloxacin | Small molecule | 400 mg | — |
| Comparator | Moxifloxacin | Small molecule | 600 mg | — |
| Comparator | Moxifloxacin | Small molecule | 800 mg | — |
| Subject | Protionamide | Small molecule | 250 mg | Oral |
| Subject | Protionamide | Small molecule | 500 mg | Oral |
| Subject | Protionamide | Small molecule | 750 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 1000 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 1500 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 2000 mg | Oral |