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| Name | Class |
|---|---|
| Peninsula Pharmaceuticals, Inc. | INDUSTRY |
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 pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.
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 complicated lower urinary tract infections (UTI) or pyelonephritis in adults. After the screening, patients are randomized to receive either doripenem or comparator. Patients are hospitalized, but subsequently, patients may be treated as outpatient or through home-based therapy at the investigators' discretion. Conventional laboratory data are collected from all patients at specified times throughout the study. The primary endpoint is microbiological response measured at test of cure visit. The patients receive either doripenum or comparator; duration of therapy is 10 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doripenum | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological response measured at test of cure visit at early follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 will be conducted throughout the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21303745 | Derived | Redman R, Damiao R, Kotey P, Kaniga K, Davies T, Naber KG. Safety and efficacy of intravenous doripenem for the treatment of complicated urinary tract infections and pyelonephritis. J Chemother. 2010 Dec;22(6):384-91. doi: 10.1179/joc.2010.22.6.384. | |
| 20211892 | Derived | Kaniga K, Flamm R, Tong SY, Lee M, Friedland I, Redman R. Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies. Antimicrob Agents Chemother. 2010 May;54(5):2119-24. doi: 10.1128/AAC.01450-09. Epub 2010 Mar 8. |
| Label | URL |
|---|---|
| A Multicenter, Double-blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem and Levofloxacin in Complicated Lower Urinary Tract Infection or Pyelonephritis | View source |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 19670912 | Derived | Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16. doi: 10.2165/00002018-200932090-00001. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D011702 | Pyelitis |