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

NCT00229021 | Completed Phase 3

• 1 other identifier: CR005404
• Study Type: interventional
• Target: 741
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Tract Infections; Pyelonephritis

Keywords

Complicated Urinary Tract Infection; Pyelonephritis

Outcome Measures

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 will be conducted throughout the study.

Interventions

doripenum DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of complicated lower urinary tract infection or pyelonephritis

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Peninsula Pharmaceuticals, Inc.: collaborator

Related Publications (3)

• Redman R, Damiao R, Kotey P, Kaniga K, Davies T, Naber KG. Safety and efficacy of intravenous doripenem for the treatment of complicated urinary tract infections and pyelonephritis. J Chemother. 2010 Dec;22(6):384-91. doi: 10.1179/joc.2010.22.6.384.

  PMID: 21303745 DERIVED

• Kaniga K, Flamm R, Tong SY, Lee M, Friedland I, Redman R. Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies. Antimicrob Agents Chemother. 2010 May;54(5):2119-24. doi: 10.1128/AAC.01450-09. Epub 2010 Mar 8.

  PMID: 20211892 DERIVED

• Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16. doi: 10.2165/00002018-200932090-00001.

  PMID: 19670912 DERIVED

Related 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

MeSH Terms

Conditions

Urinary Tract Infections; Pyelonephritis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: December 1, 2003
• Study Completion: March 1, 2006
• Last Updated: June 10, 2011

Record last verified: 2010-04