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

Phase 1

• Conditions: Complicated Urinary Tract Infections; MedDRA version: 12.1Level: LLTClassification code 10046571Term: Urinary tract infection

• Registration Number: EUCTR2009-015953-18-PL
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-20
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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 or equivalent by an alternative method). Refer to Attachment 1, Oral Temperature Conversion Table for oral temperature equivalents by alternative methods
–Note: subjects who are not able to perceive dysuria, urinary frequency, urgency, or suprapubic or abdominal pain due to congenital or acquired spinal cord injury will be allowed to enroll with the diagnosis of asymptomatic cUTI” but are required to provide 2 study-qualifying baseline urine cultures from urine specimens obtained at least 1 hour apart (see Section 9.4, Criteria for Study Qualifying Pretreatment Baseline Urine Culture for further details)
–AND have at least 1 complicating factor (see below)
Complicating Factors for All Age Categories (3 months to <18 years of age)
–Include at least one of the following complicating factors:
?Current bladder instrumentation or presence of an indwelling catheter that is anticipated to be removed during the course of IV study drug therapy
?Use of intermittent catheterization
?Urogenital surgery within the 7 days before administration of the first dose of IV study drug
?Known functional or anatomic abnormality of the urogenital tract
?Obstructive uropathy
?Vesicoureteral reflux
?Neurogenic disturbances of micturation with significant impact on bladder emptying
?Recurrent UTI (defined as 2 or more previous UTIs within a 12-month period), or
?Evidence that the current UTI may be caused by a resistant uropathogen (including evidence that the current episode is a breakthrough infection or in a child on chronic antimicrobial suppression with unresolved vesicoureteral reflux), or
?If this is the initial UTI episode in a child 3 months to <2 years of age, the child is suspected of having an acquired or congenital structural or functional urologic abnormality
–Pyelonephritis:
Children >2 years of age
–Presenting with at least one of the following signs or symptoms:
?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 at least one of the following:
?nausea or vomiting
?costovertebral angle tenderness or flank pain
•Have a positive urinalysis (urine specimen positive for nitrite and leukocyte esterase via urine dipstick or urinalysis)
•Have a study-qualifying pretreatment baseline” urine culture specimen obtained by an acceptable method including SPA, clean urethral catheterization, indwelling urethral catheter, or mid-stream clean catch (urine specimens obtained from urine bags will not be allowed) (see

Exclusion Criteria

•Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other beta-lactam antibiotics. Note: Subjects with a history of mild non urticarial skin rash temporally related to but considered not associated with the previous use of beta-lactam antibiotics are permitted to enroll in the study. For such subjects, there must be a description of the rash and documentation by the investigator that upon review of the history it is his/her opinion that the rash was unlikely due to any of the above-mentioned classes of drugs for the subject to qualify for inclusion in the study.
•Concomitant infection including but not limited to suspected or confirmed meningitis or central nervous system infection requiring systemic antibiotic or antifungal therapy in addition to the IV study drug therapy at the time of randomization. (Clarification: possible bacteremia with the presumed same urinary pathogen is acceptable).
•Receipt of any amount of potentially therapeutic antibiotic for the treatment of the current UTI within 96 hours before obtaining the study-qualifying pretreatment baseline urine. (Exception: Subjects receiving oral antibiotics for UTI prophylaxis and are suspected to have a breakthrough UTI are eligible to enroll if all other eligibility criteria are met including obtaining a study-qualifying pretreatment baseline urine culture).
•Have received systemic antibiotic therapy for more than 24 hours since obtaining the study-qualifying pretreatment baseline urine specimen
•Intractable UTI/pyelonephritis infection anticipated to require more than 14 days of study drug therapy
•Have a permanent indwelling bladder catheter or instrumentation including nephrostomy
•Current urinary catheter that will not be removed or anticipation of urinary catheter placement that will not be removed during the course of IV study drug therapy administration. (Clarification: Intermittent straight catheterization after the IV study drug therapy administration period is acceptable).
•Complete, permanent obstruction of the urinary tract
•Confirmed fungal UTI with a colony count >=10^3 CFU/mL
•Suspected or confirmed perinephric or intrarenal abscess
•Suspected or confirmed prostatitis
•Known ileal loops
•Girls who are pregnant or are nursing a child or are menarchal, and, if sexually active, are not practicing a highly effective method of birth control (eg, prescription hormonal contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before screening and agree to continue using a highly effective method of birth control (as previously described) for 30 days after administration of the last dose of study drug therapy. Note: for all menarchal girls, confirm a negative urine or serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening, before enrolling the subject into the study.
•Have any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, or septic shock, or require vasopressor therapy if hemodynamically unstable (volume repletion for support of blood pressure without the use of pressers is allowed), or are considered unlikely to survive for the duration of the study for any other reason (approximately 7 to 8 weeks)
•The subject has any of the following cli

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified