Case Study

Merck & Co., Inc. – Study for Monitoring Antimicrobial Resistance Trends (SMART)

Company Merck & Co., Inc., Kenilworth, New Jersey, United States
Sub category of Industry R&D Pharma
Category of commitment Appropriate Use
Which product(s) Small molecule
Key focus Surveillance
Key partners of the program International Health Management Associates (IHMA)
Geographic focus Global

Rapid diagnostics for pathogen identification and antibiotic susceptibility testing are central to developing global solutions for antimicrobial resistance,” said Dr. Eliav Barr, senior vice president, Infectious Diseases and Vaccines Clinical Development, Merck Research Laboratories. “By providing OpGen with access to our archive of bacterial pathogens, we hope to expedite the development of rapid diagnostic tests and enable prompt and informed antibiotic prescribing to improve patient outcomes.

 MSD

Health needs

Surveillance studies can yield important information for identification of trends in pathogen incidence and AMR, and provide early indicators of the emergence of resistant strains. Such studies are fundamental to establishing effective strategies for limiting the spread and defining the appropriate treatment of AMR infections.

Initiative’s objective

The objectives of SMART are (1) to monitor the in vitro susceptibility of clinical bacterial isolates to antimicrobials in complicated intra-abdominal infections (cIAIs), complicated urinary tract infections (cUTIs) and respiratory infections (RTI) worldwide; (2) to identify early changes in resistance patterns of community- or hospital-acquired organisms, including those that produce extended-spectrum beta-lactamases (ESBLs); and (3) to molecularly characterize resistant bacterial isolates in order to better understand the mechanism of resistance.

Initiative’s description

The Study for Monitoring Antimicrobial Resistance Trends (SMART), one of the world’s largest surveillance studies of antimicrobial resistance, was initiated by MSD in 2002 to monitor the in vitro susceptibility of clinical isolates to 12 commonly used antibiotics in different regions of the world to survey changing trends in antibiotic susceptibility. MSD has strong longitudinal data, as many sites have been a part of SMART since its inception, and this consistency in the data is a key differentiator from other surveillance programs.

SMART currently monitors antibiotic activity against gram-negative bacteria, and isolates have been collected from patients with cIAIs since 2002, from patients with cUTIs since 2010 and from patients with RTIs since 2015. It consists of 192 sites in 54 countries, encompassing all major world regions, with plans to expand to 217 sites in 63 countries in 2018.

In November 2016, MSD announced its collaboration with OpGen, providing OpGen with access to the SMART database of over 200,000 bacterial pathogens gathered over the last 15 years in order to accelerate their development efforts in validating their rapid diagnostic tools. These tools will enable prompt and informed antibiotic prescribing to improve patient outcomes.

Impact

  • Over the last 15 years, MSD has gathered and archived over 200,000 bacterial isolates through SMART.
  • SMART consists of 192 sites in 54 countries, encompassing all major world regions, with plans to expand to 217 sites in 63 countries in 2018.
  • In 2016, more than 41,000 isolates were collected.