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Doripenem 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
doripenem
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring Complicated Urinary Tract Infections, Pyelonephritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 conducted throughout the study.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Peninsula Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00210990
    Brief Title
    Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
    Official Title
    A Multicenter, Phase 3 Study of the Safety and Effectiveness of Doripenem in 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
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 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 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.
    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 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.

    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 Infections, Pyelonephritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    403 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    doripenem
    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 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=640&filename=CR005398_CSR.pdf
    Description
    A Multicenter, Phase 3 Study to Confirm the Safety and Efficacy of Intravenous Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis

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    Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

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