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

Study Overview
=================
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.

Detailed Description
-----------------
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multi-center, randomized, prospective, double-blind study of doripenem versus comparator in the treatment of complicated lower urinary tract infections (UTI) or pyelonephritis in adults. After the screening, patients are randomized to receive either doripenem or comparator. Patients are hospitalized, but subsequently, patients may be treated as outpatient or through home-based therapy at the investigators' discretion. Conventional laboratory data are collected from all patients at specified times throughout the study. The primary endpoint is microbiological response measured at test of cure visit. The patients receive either doripenum or comparator; duration of therapy is 10 days.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Verus a Comparator Antibiotic in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

Conditions
-----------------
Urinary Tract Infections, Pyelonephritis

Intervention / Treatment
-----------------
* Drug: doripenum


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: doripenum|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological response measured at test of cure visit at early follow-up. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complicated Urinary Tract Infection, Pyelonephritis