A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Principal Inclusion Criteria:

- Cohort 1: APACHE II score between 15 and 30, inclusive; Cohort 2: BSI, HABP, VABP
patients with an APACHE II score ≤30 (cUTI and AP patients do not need to have their
APACHE II score calculated)

- Positive culture that was collected ≤96 hours prior to randomization indicating a CRE
infection, or a high likelihood of a CRE infection

- Diagnosis of BSI as defined by at least one of the following: fever, hypothermia, new
onset arterial hypotension, elevated total peripheral white blood cell (WBC) count,
increased immature neutrophils (band forms), or leukopenia

- Or, diagnosis of HABP defined as clinical signs and symptoms consistent with
pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute
or chronic-care facility, or acquired within 7 days after being discharged from a
hospitalization of ≥3 days duration

- Or, diagnosis of VABP defined by clinical signs and symptoms consistent with
pneumonia acquired after at least 48 hours of continuous mechanical ventilation

- Or, diagnosis of cUTI or AP defined by clinical signs and symptoms consistent with
cUTI or AP assessed within 24 hours prior to enrollment

Principal Exclusion Criteria:

- Cohorts 1 and 2 BSI, HABP, and VABP patients: receipt of more than 72 hours of
potentially effective antibacterial therapy; Cohort 2: cUTI and AP patients: receipt
of any potentially effective antibacterial therapy in the 48 hours prior to
enrollment

- Cohort 1 only: knowledge that index CRE infection is resistant to colistin prior to
randomization

- Objective clinical evidence for any of the following clinical syndromes that
necessitates study therapy for greater than 14 days: endovascular infection including
endocarditis, osteomyelitis, prosthetic joint infection, meningitis and/or other
central nervous system infections

- Objective clinical evidence of infectious involvement of intravascular material
potentially due to the study qualifying pathogen and not intended to be removed
within 4 calendar days of the initial positive culture

- HABP or VABP patients only: pulmonary disease that precludes evaluation of
therapeutic response including known bronchial obstruction or a history of
post-obstructive pneumonia, tracheobronchitis, primary lung cancer or malignancies
metastatic to the lung, bronchiectasis, known or suspected active tuberculosis

- cUTI or AP patients only: renal abscess, chronic bacterial prostatitis, orchitis or
epididymitis, polycystic kidney disease, one functional kidney, vesicoureteral
reflux, renal transplant, cystectomy or ileal loop surgery, fungal UTI or complete,
permanent obstruction of the urinary tract

- Patients in acute renal failure at the time of randomization

- Patients receiving intermittent hemodialysis (IHD) at the time of screening

- Pregnant or breastfeeding female patient