An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections

Inclusion Criteria:

1. Is a man or woman aged 18 to 70 years, inclusive.

2. Has pyuria (a white blood cell [WBC] count greater than 10/μL in unspun urine orgreater than or equal to 10 per high power field in spun urine).

3. Has clinical signs and/or symptoms of a complicated lower urinary tract infection (UTI) and/or acute pyelonephritis that include one or more of the following: fever (i.e, axillary temperature greater than 37.7°C), chills, malaise, flank pain, backpain, and/or costo-vertebral angle pain or tenderness and/or any symptoms of dysuria (dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinaryincontinence or worsening of pre-existing incontinence) that occur in the presence ofa functional or anatomical abnormality of the urinary tract or in the presence ofcatheterization.

4. Has a pretreatment baseline urine culture specimen obtained within 24 hours before theadministration of the first dose of study drug (NOTE: Participants may be enrolled inthis study and start intravenous (IV) study drug therapy before the Investigator knowsthe results of the baseline urine culture).

5. Requires IV antibacterial therapy for the treatment of the presumed complicated UTI (cUTI).

6. In the opinion of the investigator, is capable of understanding and complying withprotocol requirements.

7. Signs and dates a written, informed consent form and any required privacyauthorization prior to the initiation of any study procedures, or has a legallyacceptable representative sign the forms.

8. Meets protocol-specified criteria regarding the use of contraception; and 9-Is willingand able to comply with study procedures.

Exclusion Criteria:

1. Has received any investigational compound within 30 days of screening.

2. Is an immediate family member, study site employee, or is in a dependent relationshipwith a study site employee who is involved in the conduct of this study (eg, spouse,parent, child, or sibling) or may consent under duress.

3. Is a female participant who is pregnant or lactating or intending to become pregnantbefore, during, or within one month after participating in this study, or intends todonate ova during such time period.

4. Is a male participant who intends to donate sperm during the course of this study orfor 12 weeks thereafter.

5. Has participated in another clinical study within the past 30 days.

6. Has a history of allergy to or intolerance of beta-lactams (penicillins,cephalosporins or carbopenems).

7. Has signs, symptoms or history of any condition that, per protocol or in the opinionof the investigator, might compromise: 1) the safety or well-being of the participantor study staff, 2) the safety or well-being of the participant's offspring (such asthrough pregnancy or breast-feeding), or 3) the analysis of results.

8. Has received any amount of potentially therapeutic antibacterial therapy aftercollection of the pretreatment baseline urine culture and before administration of thefirst dose of study drug.

9. Has received any dose of a potentially therapeutic antibacterial agent for thetreatment of the current UTI within 48 hours before providing the pretreatmentbaseline urine culture specimen.

10. Has a current urinary catheter that is not scheduled to be removed before theEnd-of-Therapy (EOT) visit (intermittent straight catheterization during the IV studydrug administration period is acceptable).

11. Has any history of trauma to the pelvis or urinary tract within one year before thescreening visit.

12. Has any other contraindications to the medicines that are to be used in the study (according to the manufacturer's instructions).

13. Is considered unlikely to survive the four-week study period or has any rapidlyprogressing disease or immediately life-threatening illness (including acute hepaticfailure, respiratory failure or septic shock).