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

This study has been completed.
Sponsor:
Collaborator:
Peninsula Pharmaceuticals, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210990
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: April 2010
  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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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.

Enrollment: 403
Study Start Date: March 2004
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210990

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.
Investigators
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 July 24, 2014