Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02486627
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2015-06-25
Brief Title:
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection cUTI Including Acute Pyelonephritis AP
Sponsor:
Achaogen Inc
Organization:
Achaogen Inc
Study Overview
Official Title:
A Phase 3 Randomized Multicenter Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Meropenem Followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection cUTI Including Acute Pyelonephritis AP in Adults
Status:
COMPLETED
Status Verified Date:
2018-07
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:
EPIC
Brief Summary:
This was a randomized multicenter multinational double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral PO therapy in the treatment of cUTI including AP in adults
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1171-1554 | OTHER | WHO | None |
| 2015-001588-37 | EUDRACT_NUMBER | None | None |