De La Salle Health Sciences Institute’s Angelo King Medical Research Center is proud to have been selected to conduct a first of its kind pediatric trial of a novel compound against multidrug-resistant tuberculosis (MDR-TB). Unfortunately, Childhood TB remains a neglected segment of an already neglected disease. There is an estimated half a million cases of childhood TB all over the world according to the World Health Organization, which results in 64,000 deaths.
The Phase I trial aims to assess the absorption, distribution, metabolism, and elimination (pharmacokinetics) of a new medicine for pediatric MDR-TB developed by the Japanese pharmaceutical company Otsuka. The company has been conducting global studies on the compound in adult patients with MDR-TB at sites around the world, including the Philippines.
Additionally, an equally groundbreaking Phase II study at the same institution will also be conducted to evaluate the long-term safety and tolerability of the new drug in adolescents, children, and infants.
One of the major challenges with treating MDR-TB in childen is the difficulty in first diagnosing the disease in this age group. Because of a difficulty in obtaining actual microbiological evidence of the disease, doctors must often rely on signs and symptoms, which do not determine if the strain is drug resistant or not. In addition, a lack of clinical trials and child-friendly formulations of anti-TB medicines means that there is very little existing information on how to properly treat and dose children suffering from the disease.
Heading the trial is principal investigator Dr. Melchor Victor G. Frias IV, who is also DLSHSI’s vice chancellor for research as well as a practicing pediatrician and clinical epidemiologist at De La Salle University Medical Center.
“This trial is finally putting greater attention on the need to properly treat MDR-TB in children,” said Dr. Frias. “DLSHSI is proud to have been selected to conduct this work and serve as a leader in peadiatric TB research in the Philippines and globally.”
This pioneering trial aims to answer some of these questions and establish for the first time, safety and an appropriate dose range of an anti-TB compound for the pediatric population.
DLSHSI will remain at the forefront of peadiatric TB research throught the conclusion of the trials. In partnership with its dedicated team of doctors, nurses, laboratory specialits and all other staff, the Institute hopes to contribute valuable information that the TB community may use to finally address this urgent health problem.