Investigator Studies Program (MISP): Bacterial Infections
Effective January 2019, the Antibacterial Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to February 15, 2019 for the first review cycle, and up to October 18, 2019 for the second review cycle. This is a competitive process that will be conducted by the Antibacterial MISP in 2019. 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 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
    • Long term tolerability in patient populations that require extended duration (beyond 4 week) Gram positive antibiotic therapy
  • Health economics and outcomes research of the use of tedizolid phosphate in patient populations described in the above settings, in optimizing patient outcomes and healthcare utilization (e.g., but not limited to: hospital early discharge management; impact on acute hospitalization or transfer from long-term care facility to acute care institution)
  • Assessment in other infections with susceptibility to tedizolid (e.g., but not limited to: non-tuberculous mycobacteria)

  • 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 (e.g., monotherapy versus combination antipseudomonal therapy, patients at risk for drug resistant pathogens including carbapenem-R and MDR P. aeruginosa)
  • Use of ceftolozane/tazobactam in accordance with institutional antimicrobial stewardship guidance
  • Understanding disease burden, outcomes and/or resource utilization of ventilated or non-ventilated HABP or VABP
  • In-vitro susceptibility/activity of ceftolozane/tazobactam against clinical isolates obtained from clinically relevant patient populations across geographic regions where sparse data are available

Imipenem-cilastatin-relebactam (MK-7655, BLI)
  • Preclinical studies of imipenem/relebactam activity, including PK/PD investigations, and/or in vitro models (e.g., studies assessing activity against pathogens expressing KPC enzymes, including MDR strains such as those resistant to other KPC active antibiotics) in time-kill, or synergy studies
  • In vitro susceptibility of imipenem/relebactam against multidrug-resistant gram-negative organisms (e.g., susceptibility for organisms (Pseudomonas aeruginosa, Enterobacteriaceae) expressing KPC enzymes alone or in the presence of other betalactamase(s) in the US) and understanding activity against pathogens that have become resistant to other antibiotics with KPC activity.
  • In vitro susceptibility/activity of imipenem/relebactam against clinical isolates obtained from specific patient populations (e.g., hematology, transplant, or febrile neutropenic patients; residents of long-term acute care (LTAC) facilities; patient populations in whom a carbapenem was previously used, or those in whom colonization with organisms expressing KPCs or other carbapenemases other than metallo-ß-lactamases)
  • Molecular epidemiological studies of carbapenem resistance in Enterobacteriaceae and Pseudomonas aeruginosa outside of the US

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

Critical Activities and Timelines:
Activity 1st Review Cycle 2nd Review Cycle
Full Protocol Submission with Detailed Budget February 15, 2019 October 18, 2019
MISP-RC Review Meeting March 14, 2019 November 14, 2019

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.