STREAM Stage 1
The evaluation of a standardised treatment regimen of anti-tuberculosis drugs for patients with MDR-TB
Can we shorten the duration of treatment and improve outcomes for patients suffering with MDR-TB (Multi-drug resistant Tuberculosis)?
What is this study about?
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 complete their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air.
MDR-TB is much more difficult to treat than TB strains that are sensitive to the commonly used drugs. Currently the standard treatments for MDR-TB can last as long as 24 months with a success rate of no more than 50%. With an approximately 500,000 new cases every year there is an urgent need to develop shorter and more effective treatments.
A newly-developed 9-month treatment is being tested in this study based on a high dose flouroquinolone and clofazimine. The aim of this investigation is to show that this shorter treatment, which has had good results in a cohort of over 500 patients in Bangladesh but has not been evaluated in a randomised trial, is at least as effective as the lengthier treatments recommended by the World Health Organisation.
A second stage of the STREAM trial started in early 2016.
You can read about the current STREAM protocol in Trials journal.
Type of study
Who is funding the study?
The United States Agency for International Development (USAID) and the MRC.
When is it taking place?
Recruitment to STREAM Stage 1 commenced in July 2012 and was completed on 30 June 2015.
Where is it taking place?
The trial is currently taking place in Ethiopia, Mongolia, South Africa and Vietnam.
Who is included?
424 people with multidrug resistant tuberculosis have been recruited.