Pharmacokinetics of Caspofungin in Burn Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Caspofungin in Burn Patients

Conditions
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Thermal Injury

Intervention / Treatment
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* Drug: Caspofungin (drug)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Caspofungin (drug) | Drug: Caspofungin (drug)<br>* 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<br>* Other names: pharmacokinetics of caspofungin in burn patients;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean total clearance |  | 18 months | 
| mean distribution volume |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caspofungin,, burn patients,, pharmacokinetics,, optimal dose,, antifungal treatment