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

Post Date: 
2018-03-20
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Summary: 

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:

  1. Determine whether low serum antimycobacterial drug concentrations are associated with the clinical emergence of drug resistance in MDR-TB patients.
  2. Determine whether HIV seropositivity is a risk factor for low serum drug concentrations.
  3. Determine the contribution of increased DNA mutation to clinical emergence of drug resistance in patient isolates.
  4. Determine the earliest time at which mutations responsible for drug resistance can be detected during treatment
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