Investigator Studies Program (MISP): Bacterial Infections
Effective January 2022, the Antibacterial Investigator Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) up to April 11, 2022. This is a competitive process that will be conducted by the Antibacterial MISP in 2022. 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:
Imipenem-cilastatin-relebactam (MK-7655, BLI)
- 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 pulmonary infections in high-risk patient populations, including those with co-morbidities.
- 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 (>18 years of age) with cystic fibrosis, stage III or IV COPD
- pneumonias in patients in whom the prescribed antibiotics are failing despite initial susceptibilities or who do not respond to initial treatment with prior antibiotics
- demonstrating the use of ceftolozane/tazobactam in accordance with institutional antimicrobial stewardship guidance for HABP/VABP or vHABP treatment
- 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
- Studies from outside the US demonstrating the role or use of ceftolozane/tazobactam in outpatient antibiotic treatment (OPAT) programs.
- 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.
- HABP/VABP 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
- Demonstrating the use of imipenem/relebactam in accordance with institutional antimicrobial stewardship guidance for HAP/VAP and vHAP treatment
- Clinical evaluation of imipenem/relebactam for the treatment of patients with cystic fibrosis or other forms of structural lung disease such as chronic bronchiectasis, COPD
- Clinical evaluation of imipenem/relebactam for the treatment of infections with rapid growing non-tuberculous mycobacteria, Burkholderia cepacian complex
- Real world data demonstrating lower development of on-treatment resistance with imipenem/relebactam vs other agents
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:
|Protocol Submission with Detailed Budget Deadline
||April 11, 2022
|MISP-RC Review Meeting
||May 12, 2022
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