Ignite Creation Date:
2024-05-06 @ 2:08 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01970371
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2013-10-23
Brief Title:
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae CRE
Sponsor:
Achaogen Inc
Organization:
Achaogen Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae CRE
Status:
COMPLETED
Status Verified Date:
2018-09
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:
CARE
Brief Summary:
This was a Phase 3 study containing a randomized open-label superiority cohort Cohort 1 comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic either meropenem or tigecycline in the treatment of patients with bloodstream infection BSI hospital acquired bacterial pneumonia HABP or ventilator-associated bacterial pneumonia VABP due to CRE An additional cohort of patients with BSI HABP VABP complicated urinary tract infection cUTI or acute pyelonephritis AP due to CRE not eligible for inclusion in the other cohort were enrolled into a single arm Cohort 2 and treated with plazomicin-based therapy Therapeutic drug management TDM was used to help ensure that plazomicin exposures lie within an acceptable range of the target mean steady-state area under the curve AUC
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 |
|---|---|---|---|
| U1111-1151-2686 | OTHER | WHO | None |
| 2013-001997-18 | EUDRACT_NUMBER | None | None |