Status:
COMPLETED
Pharmacokinetics of Caspofungin in Burn Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Thermal Injury
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. Additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. S...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 18 - 60 years old
- burn surface : 20-60% total body surface area
- delay of injury time : 8-15 days
- lack of fungal infection
- delay of hospitalization : \> 5 days
- written informed consent
- last biological picture in 24 hours before inclusion
Exclusion
- survival inferior to 5 days
- surgical intervention planned in the next five days following inclusion
- moderate or severe hepatic impairment according to Child Plug B \> 9
- pregnancy
- allergy to caspofungin or excipients (saccharose, mannitol and frozen acetic acid)
- patient already included in other study
- concomitant administration of CYP450 inducers : rifampicin, efavirenz, phenobarbital, phenytoin, carbamazepine
- withdrawal of consent
- event (during the first 48 hours following administration) susceptible to modify pharmacokinetic parameters
- Investigator decision
- no social security insurance
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00748345
Start Date
February 1 2009
End Date
December 1 2010
Last Update
December 16 2011
Active Locations (1)
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1
Cochin
Paris, France, 75014