Thermal Injury
Conditions
Keywords
Caspofungin,, burn patients,, pharmacokinetics,, optimal dose,, antifungal treatment
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. Several investigations carried out in burn patients treated with e.g. fluconazole showed the requirement to increase daily dose in comparison with healthy volunteers. However, no pharmacokinetic data are available of caspofungin in the burn population. The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population.
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, 0.5,1 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.
Interventions
DRUGCaspofungin (drug)
pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing) | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| mean total clearance | 18 months |
| mean distribution volume | 12 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChristophe Vinsonneau, MD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed