Predictors of Resistance Emergence Evaluation in Multidrug Resistant-Tuberculosis Patients on Treatment (PREEMPT Pilot Study)

Post Date:

2018-03-20

Countries:

India

Clinical Sites:

BJGMC

Hinduja Hospital

NIRT

Summary:

This study was terminated July 26, 2019.

The Indo-JHU Clinical Research Partnership is participating in this RePORT observational cohort study led by Boston University School of Public Health that's looking at the contribution of potential causes to resistance and develop the knowledge base required to stop resistance from developing by analyzing AUC and sputum samples.

The study will enroll 400 adults with pulmonary MDR-TB, HIV positive or negative (but not unknown) at sites in Brazil and India. Enrollment is expected to occur over a 24-month period with follow up through their treatment and for 12 months after completion of their treatment.

Patients will receive the treatment as determined by their healthcare provider and country guidelines for MDR-TB treatment.

Objectives:

Determine whether low serum antimycobacterial drug concentrations are associated with the clinical emergence of drug resistance in MDR-TB patients.

Determine whether HIV seropositivity is a risk factor for low serum drug concentrations.

Determine the contribution of increased DNA mutation to clinical emergence of drug resistance in patient isolates.

Determine the earliest time at which mutations responsible for drug resistance can be detected during treatment

Staff:

Amita Gupta, MD, MHS

Rahul Lokhande, MD: Pulmonary Medicine

Vidya Mave, MD, MPH

Jeff Tornheim, MD, MPH

Collaborators:

Boston University School of Public Health, Boston, MA, USA
Vanderbilt University Medical Center, Nashville, TN, USA
Rutgers, The State University of New Jersey Medicine, Newark, NJ, USA
Medical School of FURJ, Rio de Janiero, Brazil
LAPCLIN-TB of the National Institute of Infectious Disease, Rio de Janiero, Brazil
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
University of Florida, Gainesville, FL, USA
Tuberculosis Research Unit, Boston Medical Center, Boston, MA, USA
Division of Global HIV and TB, US Centers for Disease Control and Prevention, Atlanta, GA, USA
Massachusetts Institute of Technology, Cambridge, MA, USA