Despite significant advances towards shorter and safer regimens, considerable gaps remain for the treatment of all forms of TB. Both treatment and preventive therapy for drug-resistant TB remain lengthy. Children and pregnant people have been left out of research advances, and continue to be treated with longer, more toxic, less acceptable, and sometimes less effective treatment regimens. SMART4TB aims to close these gaps through several trials geared towards gathering rigorous evidence to change policy.
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Therapeutics
Nicole Salazar-Austin
Johns Hopkins University
Gustavo Velasquez
University of California, San Francisco
Sonya Krishnan
Johns Hopkins University
Eric Nuermberger
Johns Hopkins University
Rada Savic
University of California, San Francisco
Patrick Phillips
University of California, San Francisco
Ethel Weld
Johns Hopkins University
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PRISM-TB: Drug-resistant TB, TB that can’t be cured by standard first-line antibiotics, is more difficult and expensive to treat. People receive the same length of treatment, regardless of their individual risk factors for unfavorable treatment outcomes. PRISM-TB aims to improve drug-resistant TB treatment by identifying both the right regimen and right duration, which depends on a patient’s own baseline risk of treatment failure and relapse. Learn more in the PRISM-TB study overview and on ClinicalTrials.gov.
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PRISM-TB for Kids: Children with drug-resistant TB are often treated with long, toxic, non-palatable, non-child-friendly regimens despite generally having pauci-bacillary disease that is quite treatment responsive. PRISM-TB for Kids will investigate the safety, tolerability and treatment outcomes of an all-oral, once-daily regimen of bedaquiline, delamanid, levofloxacin, and linezolid in two treatment durations, four months for children with non-severe disease and six months for children with more extensive disease.
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SMILE-TB: Drug-susceptible TB currently requires four to six months of treatment, but most children may be able to be cured with a shorter treatment of more powerful drugs. SMILE-TB will evaluate if two months of TB treatment, replacing older drugs with the powerful antibiotics rifapentine and moxifloxacin, is as safe and effective as longer treatment in children. Learn more in the SMILE-TB study overview and on ClinicalTrials.gov.
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BREACH-TB: While we lack a broadly effective vaccine, preventive therapy is crucial to prevent TB disease, especially in high-risk populations such as children, people with HIV, and pregnant people. Short-course therapy has been available for several years for preventing drug-susceptible TB, but has not been tested in all these populations, and is not effective against drug-resistant TB. BREACH-TB will test the powerful and safe anti-TB medicine bedaquiline for universal short-course TB preventive therapy. Learn more in the BREACH-TB study overview.