A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections

INTERVENTION: Trade Name: DORIBAX Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: DORIPENEM MONOHYDRATE CAS Number: 364622‐82‐2 Current Sponsor code: JNJ‐38174942 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: MAXIPIME Pharmaceutical Form: Powder for solution for infusion Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE Concentration unit: g gram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Complicated Urinary Tract Infections ; MedDRA version: 12.1 Level: LLT Classification code 10046571 Term: Urinary tract infection PRIMARY OUTCOME: Main Objective: The primary objective of this study is to establish the safety and tolerability profile of doripenem compared with that of cefepime in hospitalized children 3 months to <18 years of age with cUTI. Primary end point(s): A subject will be considered to have completed the study if he or she has received at least a partial dose of study drug therapy and completed the LFU visit. Subjects who prematurely discontinue study treatment will also be considered to have completed the study after the LFU visit. Secondary Objective: The secondary objectives are:; •To determine the clinical cure rate of doripenem compared with that of cefepime at the TOC visit ; •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the TOC visit ; •To determine the clinical improvement rate of doripenem compared with that of cefepime at the end of treatment with IV study drug therapy (EIV) visit ; •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the EIV visit ; •To determine the sustained clinical cure rate of doripenem compared with that of cefepime at the late follow‐up (LFU) visit; •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the LFU visit; •To characterize the pharmacokinetics of doripenem in hospitalized children with cUTI based on a sparse pharmacokinetic sampling scheme INCLUSION CRITERIA: •Boy or girl 3 months to <18 years of age, inclusive •Have a current episode of cUTI as indicated by the following clinical signs or symptoms: –Complicated UTI Infants 3 months to <2 years of age –Presenting with at least one of the following signs or symptoms: ?Recent weight loss ?Failure to thrive ?Abdominal pain ?Vomiting ?Diarrhea ?Irritability ?Poor feeding ?Lack of normal level of activity ?Jaundice, or ?Fever (oral temperature >=38.0 degrees C or equivalent by an alternative method). Refer to Attachment 1, Oral Temperature Conversion Table for oral temperature equivalents by alternative methods –AND has at least 1 complicating factor (see below) Children 2 to <18 years of age –Presenting with at least one of the following signs or symptoms: ?Dysuria ?Urinary frequency ?Urgency ?Suprapubic or abdominal pain ?Secondary urinary incontinence, or ?Fever (oral temperature >=38.0 degrees C