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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229021
• Other study ID #: CR005404
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: June 8, 2011
• Start date: December 2003
• Est. completion date: March 2006

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• doripenum

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Peninsula Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological response measured at test of cure visit at early follow-up.
Secondary	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.

External Links

•   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