Urinary Tract Infection Treatment with Doripenem

Protocol Description

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

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

Primary Investigator

Judith M. Martin, MD

Contact Information

For information, please contact:
Noreen Jeffrey, RN
412-692-6786
Diane Gwin RN, MSN, CCRC
412-692-6744