Investigator Studies Program (MISP): Bacterial Infections
Effective December 2020, the Antibacterial Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to April 23, 2021 for the first review cycle. This is a competitive process that will be conducted by the Antibacterial MISP in 2021. Decisions will be made on the basis of scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.

The following areas are of interest to the Investigator Studies Program Committee:

Tedizolid Phosphate
  • Assessment of tedizolid phosphate treatment and tolerability in populations with limited data in the Phase 3 program including but not limited to:
    • Oral Step down from standard of care IV therapy to tedizolid for susceptible MRSA, MSSA, or VRE infections (e.g., but not limited to: early discharge management, uncomplicated blood stream infection or ABSSSI/cSSTI management, outpatient intervention avoiding acute hospitalization)
    • Treatment of gram-positive infections in patients with diabetes mellitus or other immunocompromised conditions

For any clinical treatment proposals, a “washout period” would be strongly encouraged if tedizolid is used to replace linezolid or other antibiotics that have potential for myelosuppression or peripheral neuropathies.

  • Understanding disease burden, outcomes and/or resource utilization of ventilated or non-ventilated HABP or VABP
  • Clinical evaluation of ceftolozane/tazobactam for the treatment of proven or suspected infections in high-risk patient populations, including those with co-morbidities, different pneumonia conditions. For example:
    • pneumonias in which Gram-negative pathogens such as the ESBL producing Enterobacterales or Pseudomonas aeruginosa are common pathogens;
    • populations in which relapse/recurrence is common such as but not limited to chronic bronchiectasis, adults (>23 years of age) with cystic fibrosis, stage III or IV COPD
    • pneumonias in patients who fail or do not respond to initial treatment with prior antibiotics
  • Clinical non-interventional real-world data of ceftolozane/tazobactam in the management of Gram-negative bacteremia including septic shock
  • Real world data demonstrating lower development of resistance with ceftolozane/tazobactam vs other agents
  • Real world data of the use of ceftolozane/tazobactam in patients with polymicrobial (mixed Gram negative; Gram negative and streptococcal) infections in which the organisms are susceptible to ceftolozane/tazobactam
  • Demonstrating the use of ceftolozane/tazobactam in accordance with institutional antimicrobial stewardship guidance for HAP/VAP or vHAP treatment
  • Studies from outside the US demonstrating the role or use of ceftolozane/tazobactam in outpatient antibiotic treatment (OPAT) programs.

Imipenem-cilastatin-relebactam (MK-7655, BLI)
  • Clinical evaluation of imipenem/relebactam for the treatment of proven or suspected infections in…
    • high-risk patient populations under-represented in Phase 3 RESTORE IMI 1 and 2
      • For example: HAP/VAP with high incidence of KPC/CRE, Pseudomonas that is resistant to other cephalosporin/beta lactamase inhibitor combinations
    • Patients infected with or at risk for known multidrug-resistant pathogens (e.g., KPC CRE infections, MDR-Pseudomonas) or polymicrobial infections; this may include immunocompromised patient populations
    • Clinical studies or real world data that provide insights into the enhancement of imipenem activity by relebactam in imipenem susceptible organisms, and the clinical impact this in vitro finding may have in patients with infections with imipenem susceptible organisms.
    • Demonstrating the use of imipenem/relebactam in accordance with institutional antimicrobial stewardship guidance for HAP/VAP and vHAP treatment
    • In vitro studies of the activity of imipenem/relebactam against the more unusual organisms such as non-tuberculous mycobacteria (M abscessus complex) recovered from adult patients with cystic fibrosis or other structural lung disease

    Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US). The proposals will be collectively reviewed and selected by the Antibacterial MISP Committee.

    Critical Activities and Timelines:
    Activity 1st Review Cycle
    Protocol Submission with Detailed Budget April 23, 2021
    MISP-RC Review Meeting May 26, 2021

    MISP Information
    This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.