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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00210990

Collaborator

Peninsula Pharmaceuticals, Inc. (Industry)

403

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections Pyelonephritis	Drug: doripenem	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

403 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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.