drugset / Trial / NCT02409290

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

NCT02409290

RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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