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

NCT02409290 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	IUATLD, Inc
Phase	Phase 3
Status	COMPLETED
Enrolment	588
Start date	2016-03
Completion	2023-05-02

Conditions

• MDR-TB

Interventions

• Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline)
• Moxifloxacin
• Clofazimine
• Ethambutol
• Pyrazinamide
• Isoniazid
• Prothionamide
• Kanamycin
• Levofloxacin
• Bedaquiline

Primary outcomes

• STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) — 76 weeks
  The primary efficacy outcome of the STREAM Stage 2 comparison is status at Week 76 i.e. the proportion of patients with a favourable outcome at Week 76

Countries

Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, Uganda