Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229021
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-27
Brief Title:
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None