Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333645
Status:
UNKNOWN
Last Update Posted:
2007-04-13
First Post:
2006-06-04
Brief Title:
Prophylaxis With Caspofungin in High-Risk Liver Transplantation
Sponsor:
Grupo de Estudio de Infecciones en Transplantados
Organization:
Grupo de Estudio de Infecciones en Transplantados
Study Overview
Official Title:
Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
RECRUITING
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 is a non-comparative open multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection It is expected that the proportion of high-risk liver transplant recipients who develop a documented proven or probable per European Organization for Research and Treatment of CancerMycoses Study Group EORTCMSG modified criteria invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15 It is also expected that the incidence of serious drug-related adverse events will be less than 25
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 |
|---|---|---|---|
| 03-0409 Spanish Drug Agency | None | None | None |