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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00210990
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Peninsula Pharmaceuticals, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Microbiological response measured at test of cure visit at early follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00210990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
Official Title  ICMJE A Multicenter, Phase 3 Study of the Safety and Effectiveness of Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Tract Infections
  • Pyelonephritis
Intervention  ICMJE Drug: doripenem
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2010)
403
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
290
Actual Study Completion Date  ICMJE April 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT00210990
Other Study ID Numbers  ICMJE CR005398
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Peninsula Pharmaceuticals, Inc.
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP