An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Flomoxef; Cefepime
Intervention description: Flomoxef intravenous infusion; Cefepime intravenous infusion
Intervention MeSH terms: Cefepime
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to compare the effectiveness of antibiotic flomoxef with
      cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.
    

Eligibility criteria:

        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 or
             greater 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, back
             pain, and/or costo-vertebral angle pain or tenderness and/or any symptoms of dysuria
             (dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary
             incontinence or worsening of pre-existing incontinence) that occur in the presence of
             a functional or anatomical abnormality of the urinary tract or in the presence of
             catheterization.

          4. Has a pretreatment baseline urine culture specimen obtained within 24 hours before the
             administration of the first dose of study drug (NOTE: Participants may be enrolled in
             this study and start intravenous (IV) study drug therapy before the Investigator knows
             the 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 with
             protocol requirements.

          7. Signs and dates a written, informed consent form and any required privacy
             authorization prior to the initiation of any study procedures, or has a legally
             acceptable representative sign the forms.

          8. Meets protocol-specified criteria regarding the use of contraception; and 9-Is willing
             and 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 relationship
             with 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 pregnant
             before, during, or within one month after participating in this study, or intends to
             donate ova during such time period.

          4. Is a male participant who intends to donate sperm during the course of this study or
             for 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 opinion
             of the investigator, might compromise: 1) the safety or well-being of the participant
             or study staff, 2) the safety or well-being of the participant's offspring (such as
             through pregnancy or breast-feeding), or 3) the analysis of results.

          8. Has received any amount of potentially therapeutic antibacterial therapy after
             collection of the pretreatment baseline urine culture and before administration of the
             first dose of study drug.

          9. Has received any dose of a potentially therapeutic antibacterial agent for the
             treatment of the current UTI within 48 hours before providing the pretreatment
             baseline urine culture specimen.

         10. Has a current urinary catheter that is not scheduled to be removed before the
             End-of-Therapy (EOT) visit (intermittent straight catheterization during the IV study
             drug administration period is acceptable).

         11. Has any history of trauma to the pelvis or urinary tract within one year before the
             screening 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 rapidly
             progressing disease or immediately life-threatening illness (including acute hepatic
             failure, respiratory failure or septic shock).