imipenem/relebactam/cilastatin versus piperacillin/tazobactam for treatment of participants with bacterial pneumonia (mk-7655a-014)

Conditions: Bacterial Pneumonia

Summary: this study aims to compare treatment with a fixed-dose combination (fdc) of imipenem/relebactam/cilastatin (imi/rel) with a fdc of piperacillin/tazobactam (pip/taz) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (habp or vapb, respectively). the primary hypothesis is that imi/rel is non-inferior to pip/taz in the incidence rate of all-cause mortality.


Eligibility criteria:
inclusion criteria: * requires treatment with iv antibiotic therapy for hospital-acquired bacterial pneumonia (habp) or ventilator-associated bacterial pneumonia (vabp) * fulfills clinical and radiographic criteria, with onset of criteria occurring after more than 48 hours of hospitalization or within 7 days after discharge from a hospital (for habp); or at least 48 hours after mechanical ventilation (for vabp) * has an adequate baseline lower respiratory tract specimen obtained for gram stain and culture * has an infection known or thought to be caused by microorganisms susceptible to the iv study therapy * agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the central microbiology reference laboratory for study-related microbiological testing, long term storage, and other future testing * is not of reproductive potential; or if of reproductive potential agrees to avoid impregnating a partner or avoid becoming pregnant, by practicing abstinence or using acceptable contraception exclusion criteria: * has a baseline lower respiratory tract specimen gram stain that shows the presence of gram-positive cocci only * has confirmed or suspected community-acquired bacterial pneumonia (cabp) * has confirmed or suspected pneumonia of viral, fungal or parasitic origin * has habp/vabp caused by an obstructive process, including lung cancer or other known obstruction * has a carcinoid tumor or carcinoid syndrome * has active immunosuppression defined as either receiving immunosuppressive medications or having a medical condition associated with immunodeficiency * is expected to survive for less than 72 hours * has a concurrent condition or infection that would preclude evaluation of therapeutic response * has received effective antibacterial drug therapy for the index infection of habp/vabp for more than 24 hours continuously, during the previous 72 hours * has a history of serious allergy, hypersensitivity or a serious reaction to any penicillin or beta-lactamase inhibitors * female is pregnant, expecting to conceive, is breastfeeding or plans to breastfeed * has a history of seizure disorder requiring ongoing prior treatment with anti-convulsive therapy within the last 3 years * anticipates treatment with the following: valproic acid or divalproex sodium, serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin receptor antagonists, meperidine, buspirone, concomitant systemic antibacterial agents, antifungal or antiviral therapy for the index infection of habp/vabp * is currently undergoing hemodialysis or peritoneal dialysis * is currently participating in, has participated in during the previous 30 days, or anticipates to participate in any other clinical study involving the administration of experimental medication * has previously participated in this study