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	Intervention	Phase
Urinary Tract Infections Pyelonephritis	Drug: Doripenem	Phase III

Further Study Details: 

Primary Outcomes: Microbiological response measured at test of cure visit at early follow-up.
Secondary Outcomes: 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.
Expected Total Enrollment:  290

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 doripenum with duration of therapy up to 10 days.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00210990

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial,  Study Director,  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.   

Study ID Numbers:  CR005398
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00210990
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27