Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211003
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
Doripenem in the Treatment of Hospital-Acquired Pneumonia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Randomized Open-Label Phase 3 Study to Compare the Safety and Effectiveness of Doripenem Versus a Comparator Antibiotic in Hospital-Acquired Pneumonia
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 safety and effectiveness of doripenem in patients with hospital-acquired pneumonia HAP
Detailed Description:
Doripenem is an antibiotic medication not yet approved by the US FDA This is a phase 3 multicenter prospective open-label though with blinded outcome assessments randomized study of doripenem versus a comparator antibiotic in patients with hospital-acquired pneumonia The study consists of screening phase open-label treatment phase and follow-up Both patients on ventilator and not on ventilator are enrolled The primary endpoint is the clinical response rate at early follow-up visit The patients may receive either doripenem or comparator total duration of the treatment is 7 to 14 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