Study of the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for the Treatment of Complicated Urinary Tract Infection (cUTI) (MK-7655-003)

Inclusion Criteria:

- Clinically suspected and/or bacteriologically documented cUTI or acute

pyelonephritis judged by the investigator to be serious (requiring hospitalization and
treatment with IV antibiotic therapy)

- Pyuria, determined by a midstream clean-catch (MSCC) or catheterized

(indwelling or straight catheter) urine specimen with greater than or equal to 10 white
blood cells (WBCs) per high-power field (hpf) on standard examination of urine sediment or
greater than or equal to 10 WBCs/mm3 in unspun urine

- One positive urine culture within 48 hours of enrollment

Exclusion Criteria:

- Complete obstruction of any portion of the urinary tract (requiring a

permanent indwelling urinary catheter or instrumentation), a known ileal loop, or
intractable vesico-ureteral reflux

- A temporary indwelling urinary catheter is in place and cannot be removed at study
entry.

- Perinephric or intrarenal abscess or known or suspected prostatitis

- Uncomplicated UTI

- Any history of recent accidental trauma to the pelvis or urinary tract

- Any amount of effective antibiotic therapy after obtaining the urine culture for
admission to this study and prior to the administration of the first dose of IV study
therapy

- An infection which has been treated with greater than 24 hours of systemic antibiotic
therapy known to be effective against the presumed or documented etiologic
pathogen(s) within the 72-hour period immediately prior to consideration for entry
into the study

- History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any

serious reaction to carbapenem antibiotics, any cephalosporins, penicillins, or other beta
(β)-lactam agents

- History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious
reaction to other beta-lactam inhibitors (e.g., tazobactam, sulbactam, clavulanic
acid)

- History of a seizure disorder

- Currently being treated with valproic acid or has received treatment with

valproic acid in the 2 weeks prior to screening.

- Rapidly progressive or terminal illness unlikely to survive the approximately 6 to 8
week study period

- Pregnant or expecting to conceive, breast feeding, or plans to breast feed

during the study

- A response to all study therapy (IV study therapy or subsequent oral

ciprofloxacin) within the timeframe of treatment specified in this protocol is

considered unlikely.

- Concurrent infection that would interfere with evaluation of response to

the study antibiotics

- Need for concomitant systemic antimicrobial agents in addition to those

designated in the various study treatment groups (use of vancomycin, daptomycin, or
linezolid is allowed for certain infections)

- cUTI due to a confirmed fungal pathogen

- Currently receiving immunosuppressive therapy, including use of high-dose

corticosteroids

- Prior recipient of a renal transplantation

- Laboratory abnormalities as specified in protocol

- History of any other illness that, in the opinion of the investigator, might

confound the results of the study or pose additional risk in administering the study drug

- Currently participating in, or has participated in, any other clinical study

involving the administration of investigational or experimental medication (not

licensed by regulatory agencies) at the time of presentation or during the previous 30
days prior to screening or is anticipated to participate in such a clinical study during
the course of this trial

- Estimated or actual creatinine clearance of <5 mL/minute, or is currently undergoing
hemodialysis