Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)

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 hour 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