Feasibility Study Complete on Preventive Therapy for Household Contacts of
Published by BWI-CTU
March 31, 2016—Pune, India—The Baltimore-Washington-India Clinical Trials Unit is pleased to announce that the BJGMC Clinical Research Site (BJGMC-CRS) in Pune, India, just finished the feasibility study titled A5300/IMPAACT2003: Study of MDR-TB Cases and their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design.
Funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, the feasibility study was successfully completed with support from the Revised National Tuberculosis Control Programme (RNTCP), Pune, India. The BJGMC-CRS had the second highest participant enrollment among all study sites during the feasibility phase.
The main study is a large, 8-year, multi-country trial that will be conducted on 5 continents to determine the efficacy of a new drug to prevent development of TB among the household contacts of TB patients. WHO currently has no guidelines for TB prevention for people living with TB patients. Specifically, the main study will compare whether preventive treatment with delamanid substantially reduces the risk of developing TB versus treatment with isoniazid preventive therapy in child, adolescent, and adult household contacts of MDR-TB patients.
BJGMC-CRS Community Advisory Board (CAB) met in Pune, India, March 18, 2016, to conclude the feasibility phase of the trial. Savita Kanade (Community Coordinator and CAB liaison, BJGMC-CRS) and Dr. Nishi Suryavanshi (BJGMC-CRS Coordinator) and Prasanna Sahoo (Outreach Coordinator, BJGMC-CRS) concluded the study update and acknowledged the support of RNTCP, specifically honoring the contributions of Mr. Sachin Patil (PCMC), Mr. Bharat Gundal (PMC) and Ms. Pratima Vanjari (Rural). Geeta Pardeshi (PMC) accepted the honor on behalf of Pratima Vanjari, who was unable to attend.