The National Institute of Allergy and Infectious Diseases and the National Institute of Child Health and Human Development of the United States’ National Institutes of Health (NIH) has chosen De La Salle Health Sciences Institute (DLSHSI) to be a clinical trial site in a global study on tuberculosis. DLSHSI is the first in the Philippines to be tapped by NIH as a Clinical Research Site (CRS).
The AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT)-sponsored multi-country study entitled “Protecting Household Contacts on Exposure to Newly Diagnosed Index Multi-Drug Resistant Tuberculosis Patients (Phoenix MDRTB)” aims to protect and prevent children and other family members from getting infected with tuberculosis after a member of the household contracts multi-drug resistant tuberculosis. In the Philippines, the challenge of controlling TB has become more difficult with many patients developing multi-drug resistant tuberculosis, and as a result, exposing children and other members of their household to this more severe disease.
Dr. Melchor Victor Frias IV of DLSHSI’s College of Medicine and former vice chancellor for Research at DLSHSI will be the Clinical Research Site leader and Principal Investigator.
As a trial site, DLSHSI will receive funding from the NIH through the Emory University (Emory) – Center for Disease Control (CDC) Clinical Trials Unit (CTU). DLSHSI will be responsible for conducting the trial which includes providing qualified personnel, equipment, materials, facilities, and patient recruitment, enrollment, and completing the required visits with the guidance and support of the Emory-CDC CTU.
On September 19, 2017, representatives from Emory University, signed a Core Funding Agreement with DLSHSI President Br. Gus Boquer FSC to start up the study. Emory University is a leading research institution, medical, education and health facility based in Atlanta Georgia in the US and is one of the clinical trial units of the NIH.
“More and more cases of MDR-TB are being diagnosed each year not only in the Philippines but in other TB high burden countries as well. For me, this can be regarded as either good or bad or perchance, both. It may be bad because it can reflect as an increasing public health problem. It may be good as it reflects a significant improvement in case finding and confirmation methods consequently increasing the number of patients being aptly treated. Ultimately, this will redound to reduction in complications and deaths due to MDR-TB and prevent early transmission of the disease.
“However, as a physician, my duty does not end with the diagnosis and treatment of a patient with MDR- TB, I am also accountable to those who are exposed to the disease. Aside from screening for active TB disease for two years through chest x-ray, monitoring and assessment of signs and symptoms, and other diagnostics such as sputum culture and geneXpert, there is not much that we can provide in terms of preventive therapy to those who would have latent infection or test negative for active disease. There is a potential risk for MDR-TB among exposed household contacts and managing them is an important gap that needs to be urgently addressed. This study addresses that gap as there is lack of high-quality evidence whether protecting household contacts of MDR-TB patients through preventive therapy is beneficial and if so, which drugs are effective. More significantly, this study is a way of reassuring an average 4-5 household members exposed to an MDR-TB patient in the Philippines that we are not only thinking of the welfare of those afflicted with MDR-TB but theirs as well,” said Dr. Frias.