Pharmacokinetics of Caspofungin in Burn Patients (Caspo-brûlés)

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.

Study Overview

• Status: Completed
• Conditions: Thermal Injury
• Intervention / Treatment: Drug: Caspofungin (drug)

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: pharmacokinetics of caspofungin in burn patients

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 31, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 8, 2008

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics,; antifungal treatment; Caspofungin,; burn patients,; optimal dose,
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Caspofungin
• Other Study ID Numbers: P070601