Research

Urinary Tract Infection Treatment with Doripenem

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

Protocol Description

The purpose of this multi-center international study is to evaluate the safety and tolerability of the antibiotic doripenem in babies, children and teens, hospitalized with complicated urinary tract infections (UTI). Doripenem is approved by the U.S. Food and Drug Administration for use by adults, but its application for children is still being investigated. This study will compare its effects to those of cefepime, a drug currently approved to treat UTI in children.

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders, ages 3 months through 17 years, who have a UTI that requires treatment with intravenous (IV) antibiotics in the hospital.
Boys: Ages 3 months through 17 years
Girls: Ages 3 months through 17 years

Requirements
In addition to receiving a physical examination, including blood and urine sample collection, participants will be randomly assigned to one of two study groups. One group will receive intravenous doses of doripenem and the other will receive cefepime. Researchers will note how quickly the child improves, based on absence of fever and reduced or no bacteria growth in urine sample. When improvement is shown, doctors will prescribe antibiotic pills or liquid antibiotics that can be taken at home or in the hospital.
Visits: Hospitalization plus 3 follow-up visits
Duration: 10 to 14 days of treatment and up to 42 more days for follow-up

Status: Open for Enrollment

Source(s) of Support
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information
Study description at National Institutes of Health