A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Complicated Urinary Tract Infections or Pyelonephritis

In brief

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.

Key facts

Study ID

NCT01110408

Run by

Janssen Research & Development, LLC

People needed

41

Starts

2010-12-01

Expected to finish

2013-06-01

Last updated by the study team

2014-07-15

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are eligible for the study must have a current episode of cUTI or pyelonephritis
• Have evidence of pyuria that meets criteria specified in the study protocol
• Have a study-qualifying pretreatment "baseline" urine culture specimen obtained by an acceptable method within 48 hours before the start of the administration of the first dose of iv study drug from which a bacterial pathogen is isolated with a growth of >= 100000 colony forming units (CFU)/mL
• Require hospitalization initially and 10 to 14 days of antibacterial therapy [of which at least 72 hours should be iv therapy] for the treatment of the presumed UTI
• Have a signed informed consent form completed by the patient's parent or legal representative (and a signed assent form obtained from patients who are capable of providing assent, typically, children 7 years of age or older)

You may not qualify if…

• Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other beta-lactam antibiotics
• 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
• Receipt of any amount of systemic antibiotic within 96 hours before obtaining the study-qualifying pretreatment baseline urine or systemic antibiotic therapy for more than 24 hours after obtaining the study-qualifying pretreatment baseline urine specimen
• Have a diagnosis of intractable UTI/pyelonephritis infection anticipated to require more than 14 days of study drug therapy, a permanent indwelling bladder catheter or instrumentation including nephrostomy or 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, complete and permanent obstruction of the urinary tract, confirmed fungal UTI, suspected or confirmed perinephric or intrarenal abscess, suspected or confirmed prostatitis, known ileal loops, or any of the following clinically significant laboratory abnormalities: absolute neutrophil count (ANC) <500 cells/µL, platelet count <40,000 cells/µL, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >5x the age-specific upper limit of normal (ULN), acute or chronic renal insufficiency with a baseline creatinine clearance <60 mL per minute or requires dialysis therapy for any reason
• Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6 months before randomization

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Loma Hermosa, Argentina
• Study site — Santa Fe, Argentina
• Study site — Belo Horizonte, Brazil
• Study site — Caxias do Sul, Brazil
• Study site — Passo Fundo, Brazil
• Study site — São Paulo, Brazil
• Study site — Santiago, Chile
• Study site — Valdivia X Región, Chile
• Study site — Bogotá, Colombia
• Study site — Cali, Colombia
• Study site — Floridablanca, Colombia
• Study site — Medellín, Colombia

Full record on ClinicalTrials.gov

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