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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: Microbiological response measured at test of cure visit at early follow-up.

Original Primary Outcome: Same as current

Current Secondary Outcome: 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.

Original Secondary Outcome: Same as current

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: September 13, 2005
Date Started: March 2004
Date Completion:
Last Updated: June 8, 2011
Last Verified: April 2010