Ignite Creation Date:
2025-12-17 @ 8:49 PM
Ignite Modification Date:
2025-12-23 @ 5:46 PM
Study NCT ID:
NCT00748345
Status:
None
Last Update Posted:
2011-12-16 00:00:00
First Post:
2008-07-31 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Caspofungin in Burn Patients
Sponsor:
None
Organization:
Study Overview
Official Title:
Pharmacokinetics of Caspofungin in Burn Patients
Status:
None
Status Verified Date:
2011-07
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:
Caspo-brûlés
Brief Summary:
The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.). Blood samples are drawn just before administration and 0.25, 0.5,1 1.5, 3, 6, 12, 24, 48, 72, 96 and 120 hours after administration. Caspofungin plasma concentrations are measured by liquid-chromatography spectrometry mass tandem.The primary end-points are :
* area under the curve of caspofungin plasma concentrations over 24 hours
* mean peak level and trough concentration (24 hours after dosing)
The secondary end-points are :
* mean total clearance
* mean distribution volume These parameters will be compared to those usually observed in non burn patients. The optimal dose in burn patients is the dose achieving an exposure similar to that in non burn patients.
* area under the curve of caspofungin plasma concentrations over 24 hours
* mean peak level and trough concentration (24 hours after dosing)
The secondary end-points are :
* mean total clearance
* mean distribution volume These parameters will be compared to those usually observed in non burn patients. The optimal dose in burn patients is the dose achieving an exposure similar to that in non burn patients.
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?: