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NCT Number: NCT00210990

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Pyelonephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doripenem

Drug

Primary outcomes

  1. Microbiological response measured at test of cure visit at early follow-up.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Collaborators

  • Peninsula Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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