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Caspo-brûlés: Pharmacokinetics of Caspofungin in Burn Patients

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00748345
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
21.9
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Feb 1, 2009
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    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) [18 months]

    Secondary Outcome Measures

    1. mean total clearance [18 months]

    2. mean distribution volume [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cochin Paris France 75014

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT00748345
    Other Study ID Numbers:
    • P070601
    First Posted:
    Sep 8, 2008
    Last Update Posted:
    Dec 16, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Caspofungin,
    burn patients,
    pharmacokinetics,
    optimal dose,
    antifungal treatment
    Additional relevant MeSH terms:
    Caspofungin

    Study Results

    No Results Posted as of Dec 16, 2011