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

Urinary Tract Infections Clinical Trial

Official title:

A Multicenter, Phase 3 Study of the Safety and Effectiveness of Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210990
• Other study ID #: CR005398
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 8, 2011
• Start date: March 2004
• Est. completion date: April 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: April 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• doripenem

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 conducted throughout the study.

External Links

•   A Multicenter, Phase 3 Study to Confirm the Safety and Efficacy of Intravenous Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis