Pharmacokinetics of Caspofungin in Burn Patients (Caspo-brûlés)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Thermal Injury	Drug: Caspofungin (drug)	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pharmacokinetics of Caspofungin in Burn Patients
Study Start Date :	February 2009
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Caspofungin (drug)	Drug: Caspofungin (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; Other Name: pharmacokinetics of caspofungin in burn patients

Outcome Measures

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Primary Outcome Measures :

1. area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing) [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. mean total clearance [ Time Frame: 18 months ]
2. mean distribution volume [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

France
Cochin
Paris, France, 75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Christophe Vinsonneau, MD	Assistance Publique - Hôpitaux de Paris

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00748345 History of Changes
Other Study ID Numbers:	P070601
First Posted:	September 8, 2008
Last Update Posted:	December 16, 2011
Last Verified:	July 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Caspofungin,; burn patients,; pharmacokinetics,; optimal dose,; antifungal treatment

Additional relevant MeSH terms:

Caspofungin; Echinocandins; Antifungal Agents; Anti-Infective Agents