A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection
The primary purpose of this study is to evaluate the safety and tolerability of
imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of
age with confirmed or suspected gram-negative bacterial infection. Participants are expected
to require hospitalization through completion of intravenous (IV) study intervention, and
have at least one of the following primary infection types: hospital-acquired bacterial
pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated
intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants
will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also
evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28
post-randomization, as well as clinical and microbiological response to treatment. It will
also evaluate the pharmacokinetics of IMI/REL.
Suspected or Documented Gram-negative Bacterial Infection
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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