Status:
COMPLETED
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Peninsula Pharmaceuticals, Inc.
Conditions:
Urinary Tract Infections
Pyelonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 character...
Detailed 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 urin...
Eligibility Criteria
Inclusion
- Diagnosis of complicated lower urinary tract infection or pyelonephritis
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00210990
Start Date
March 1 2004
End Date
April 1 2006
Last Update
June 10 2011
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