Complicated Urinary Tract Infections MedDRA version: 14.1 Level: PT Classification code 10046571 Term: Urinary tract infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Have evidence of pyuria as demonstrated by either of the following: o A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis o A urine specimen with =10 WBCs per microliter from an unspun sample or =5 WBCs per high power field from a centrifuged specimen. 2- Have a current documented or suspected cUTI or pyelonephritis as indicated by the following clinical signs or symptoms: COMPLICATED URINARY TRACT INFECTION o Symptomatic cUTI Children 3 months to 38.0C, tympanic temperature >38.3C, or rectal or core temperature >38.8C) or hypothermia (rectal or core temperature or=15,000 cells/microL OR >or=15% immature neutrophils, regardless of the total peripheral white cell count AND Have at least ONE of the following signs or symptoms: Children 3 months to <2 years of age – Vomiting – Recent weight loss or failure to thrive – A
Exclusion criteria
Exclusion criteria: 1 - 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. 2 - Concomitant infection including but not limited to suspected or confirmed meningitis or other central nervous system infection requiring systemic antibiotic or antifungal therapy at the time of randomization. (Clarification: possible bacteremia with the presumed same urinary pathogen is acceptable). 3 - Received any amount systemic antibiotic therapy within 96 hours (4 days) before obtaining the pretreatment baseline urine culture specimen. (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 baseline urine culture specimen). 4 - Have received more than 24 hours of systemic antibiotic therapy after obtaining the pretreatment baseline urine culture specimen 5 - 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 do not 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. 6 - Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6 months before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 (complicated Urinary Tract Infection).;Secondary Objective: The secondary objectives are: •To determine the clinical cure rate of doripenem compared with that of cefepime at the TOC (Test Of Cure) 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;Primary end point(s): Adverse events, Clinical laboratory tests and Vital signs measurements;Timepoint(s) of evaluation of this end point: Baseline up to 42 days after the last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - To determine the clinical cure rate and favorable microbiological response rate of doripenem compared with that of cefepime at the test of cure (TOC) visit 2 - To determine the clinical improvement rate and favorable microbiological response rate of doripenem compared with that of cefepime at the end of treatment with iv study drug therapy (EIV) visit 3 - To determine the sustained clinical cure rate and favorable microbiological response rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit 4 - To characterize the pharmacokinetics of doripenem in hospitalized children with cUTI on the basis of a sparse pharmacokinetic sampling scheme;Timepoint(s) of evaluation of this end point: 1 - 7 to 14 days after the last dose of iv study drug including oral antibiotic therapy 2 - Within 24 hours after completion of the last dose of iv study drug 3 - 28 to 42 days after the last dose of iv study drug including oral antibiotic therapy 4 - 1, 2, 4 and 6 hours after the 4th, 5th, 6th, or 7th dose administrations of doripenem/doripenem placebo | — |
Countries
Argentina, Brazil, Colombia, Czech Republic, Germany, India, Latvia, Lithuania, Mexico, Panama, Poland, Uganda, Ukraine, United States
Contacts
Public ContactClinical Registry Group
Janssen- Cilag International NV
Outcome results
None listed