Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to assess the microbiological cure rate of doripenem in the treatment of patients with complicated urinary tract infection or pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.
Full description
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multi-center, prospective, open-label, single-arm study of doripenem in the treatment of complicated lower urinary tract infection or pyelonephritis in adults. Patients are hospitalized, but subsequently, patients may treated as outpatient or through home-based therapy at the discretion of the investigators. Conventional laboratory data will be collected from patients at specified times throughout the study. The primary endpoint is microbiological response measured at test of cure visit. The patients will receive doripenem with duration of therapy up to 10 days.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosis of complicated lower urinary tract infection or pyelonephritis
Exclusion criteria
- Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control
- History of moderate or severe hypersensitivity reactions to antibiotic medications
Trial design
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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