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 compare the microbiological cure rate of doripenem versus a comparator antibiotic in the treatment of patients with complicated urinary tract infection or pyelonephriti...
Detailed Description
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multi-center, randomized, prospective, double-blind study of doripenem versus comparator in the treatment of co...
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 :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
741 Patients enrolled
Trial Details
Trial ID
NCT00229021
Start Date
December 1 2003
End Date
March 1 2006
Last Update
June 10 2011
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