Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Tract Infections Pyelonephritis |
Drug: doripenem |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Phase 3 Study of the Safety and Effectiveness of Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis |
- Microbiological response measured at test of cure visit at early follow-up.
- Clinical response (cure) assessed at early follow-up visit. Proportion of patients with sustained microbiological and clinical response measured at late follow-up visit. Safety evaluations conducted throughout the study.
| Enrollment: | 403 |
| Study Start Date: | March 2004 |
| Study Completion Date: | April 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00210990 History of Changes |
| Other Study ID Numbers: | CR005398 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Complicated Urinary Tract Infections Pyelonephritis |
Additional relevant MeSH terms:
|
Pyelonephritis Urinary Tract Infections Nephritis, Interstitial Nephritis |
Kidney Diseases Urologic Diseases Pyelitis Infection |
ClinicalTrials.gov processed this record on June 17, 2013