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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00229021

Enrollment

741

Registered

2005-09-29

Start date

2003-12-31

Completion date

2006-03-31

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyelonephritis, Urinary Tract Infections

Keywords

Complicated Urinary Tract Infection, Pyelonephritis

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.

Interventions

DRUGdoripenum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Microbiological response measured at test of cure visit at early follow-up.	—

Secondary

Measure	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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026