Back to resultsDoripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
Primary Purpose
Urinary Tract Infections, Pyelonephritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
doripenum
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections focused on measuring Complicated Urinary Tract Infection, Pyelonephritis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Microbiological response measured at test of cure visit at early follow-up.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00229021
First Posted
September 27, 2005
Last Updated
June 8, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Peninsula Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00229021
Brief Title
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
Official Title
A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Verus a Comparator Antibiotic in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Peninsula Pharmaceuticals, Inc.
4. Oversight
5. Study Description
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 pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Pyelonephritis
Keywords
Complicated Urinary Tract Infection, Pyelonephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
741 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
doripenum
Primary Outcome Measure Information:
Title
Microbiological response measured at test of cure visit at early follow-up.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21303745
Citation
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.
Results Reference
derived
PubMed Identifier
20211892
Citation
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.
Results Reference
derived
PubMed Identifier
19670912
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=642&filename=CR005404_CSR.pdf
Description
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
Learn more about this trial
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
We'll reach out to this number within 24 hrs