Susan Swindells, M.B.B.S., professor of internal medicine-infectious diseases at UNMC, is one of four internationally recognized scientists to lead a large international clinical research study. The study will compare two drugs in an effort to prevent multidrug-resistant tuberculosis (MDR-TB) in the home setting.
The study is comparing the safety and effectiveness of delamanid, a new drug to treat TB, with isoniazid to prevent MDR-TB in children, adolescents and adults who are exposed to adult household members with MDR-TB. Globally, TB is the most common illness in people living with HIV, and it is the major cause of HIV-related deaths.
The study will take place at more than 27 sites in at least 12 countries and will enroll about 5,610 participants -- 2,158 with active MDR-TB and 3,452 members of these households who are at high risk for developing active TB disease. Without adequate preventive care, many individuals will progress to active MDR-TB disease, in which the bacteria become active and multiply.
As protocol chair, Dr. Swindells is responsible for the development and implementation of the randomized study for site selection and interaction with the National Institutes of Health and drug companies that make drugs in the study. Other study chairs are located at Johns Hopkins University in Baltimore, the Desmond Tutu TB Centre in Cape Town, South Africa, and the Aurum Institute for Health Research in Johannesburg, South Africa.
"If someone gets multidrug-resistant tuberculosis, we can treat the source patients, but we don't know what to do with all the people in the house being exposed," Dr. Swindells said. "It's a big question worldwide, but it also might be relevant in Nebraska."
"If you live with someone with tuberculosis -- and it depends on your overall health -- you have a greatly increased chance of getting it. We want a treatment to prevent others from getting the disease."
From 2007 to 2016, Dr. Swindells said 279 cases of TB in Nebraska were reported, an average of about 25-30 cases a year. However, according to the World Health Organization, worldwide there were 10 million new cases in 2017 and 1.6 million died. An estimated 460,000 of the new cases had MDR-TB.
The Phase 3 clinical research study, called PHOENIx MDR-TB, is funded by the NIH, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the AIDS Clinical Trials Group and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, both of which are funded by NIH. The manufacturer of delamanid, Otsuka Pharmaceutical Co., Ltd. of Tokyo, is donating the drug used in the trial.
Congratulations Dr. Swindells. As someone whose family member was one of the few people in Nebraska who contracted TB, I know first hand how devastating this disease is. That there is a multi-drug resistant strain is even scarier. I will pray for your success!
I love this team! They have been doing amazing work for years, led by an extraordinary woman. Thank you for all you do Dr. Swindells.