Ignite Creation Date:
2024-05-05 @ 10:23 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01096849
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2010-03-12
Brief Title:
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection cUTI and Acute Pyelonephritis AP
Sponsor:
Achaogen Inc
Organization:
Achaogen Inc
Study Overview
Official Title:
A Double-blind Randomized Comparator-controlled Study to Assess the Safety Efficacy and Pharmacokinetics of ACHN-490 Injection Administered IV in Patients With Complicated Urinary Tract Infections or Acute Pyelonephritis
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a multi-center multi-national double-blind randomized comparator-controlled study of plazomicin administered intravenously compared with levofloxacin a standard approved intravenous therapy for complicated urinary tract infection cUTI and acute pyelonephritis AP
Detailed Description:
None
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