Investigator Studies Program (MISP): Bacterial Infections

Effective January 2023, the Antibacterial Investigator Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) up to April 11, 2023. This is a competitive process that will be conducted by the Antibacterial MISP in 2023. 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:Ceftolozane/Tazobactam

• Clinical utilization of ceftolozane/tazobactam for the treatment of proven or suspected pulmonary infections in high-risk patient populations, including those with comorbidities.


• Clinical non-interventional real-world data of ceftolozane/tazobactam in the management of gram-negative bacteremia including septic shock


• Real world data evaluating the development of resistance while on therapy with ceftolozane/tazobactam and other antibiotics


• Studies from outside the US demonstrating the role or use of ceftolozane/tazobactam in outpatient antibiotic treatment (OPAT) programs.


• Use of ceftolozane/tazobactam in pediatric populations (age 0 to < 18 years of age) with cystic fibrosis.

Imipenem-cilastatin-relebactam (MK-7655, BLI)

• Studies on the use of imipenem/relebactam in accordance with institutional antimicrobial stewardship guidance for HABP/VABP and vHABP treatment


• Clinical evaluation of imipenem/relebactam for use in the combination treatment regimens of infections with rapid growing non-tuberculous mycobacteria, Burkholderia cepacia complex.

• Real world studies evaluating the development of on-treatment resistance with imipenem/relebactam and other antibiotics


• Studies of the use of imipenem/relebactam in an outpatient setting (OPAT)


• Studies of the use of imipenem/relebactam in the treatment of Gram negative bacterial infections, including molecular analysis of clinical isolates which may include the presence of OXA 48 or OXA 48 like betalactamase, or KPCs.

• Real World data of imipenem/relebactam for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), HABP/VABP caused by difficult to treat pathogens, which may include:

• Carbapenem-resistant Pseudomonas aeruginosa and difficult-to-treat PseudomonasCarbapenemase producing (KPC) Klebsiella pneumoniae.
• Other difficult to treat or MDR GN bacteria.

• This may include the clinical evaluation of imipenem/relebactam + another class of antibiotic (for example Fosfomycin or aztreonam) for the treatment of these organisms

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

Critical Activities and Timelines:

Activity	Review Cycle
Protocol Submission with Detailed Budget Deadline	April 11, 2023
MISP-RC Review Meeting	May 11, 2023

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.