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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00210990

Enrollment

403

Registered

2005-09-21

Start date

2004-03-31

Completion date

2006-04-30

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 Infections, Pyelonephritis

Brief summary

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.

Detailed description

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.

Interventions

DRUGdoripenem

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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 conducted throughout the study.	—

Outcome results

None listed

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