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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:
NCT00229021
First received: September 27, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infections
Pyelonephritis
Drug: doripenum
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

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 will be conducted throughout the study.

Enrollment: 741
Study Start Date: December 2003
Study Completion Date: March 2006
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.

  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: NCT00229021

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: NCT00229021     History of Changes
Other Study ID Numbers: CR005404
Study First Received: September 27, 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 Infection
Pyelonephritis

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pyelonephritis
Urinary Tract Infections
Kidney Diseases
Nephritis
Nephritis, Interstitial
Pyelitis
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014