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Pharmacokinetics of Caspofungin in Burn Patients (Caspo-brûlés)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00748345
First received: July 31, 2008
Last updated: December 15, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Thermal Injury
Drug: Caspofungin (drug)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Caspofungin in Burn Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean total clearance [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • mean distribution volume [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748345

Locations
France
Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Christophe Vinsonneau, MD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00748345     History of Changes
Other Study ID Numbers: P070601
Study First Received: July 31, 2008
Last Updated: December 15, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Caspofungin,
burn patients,
pharmacokinetics,
optimal dose,
antifungal treatment

Additional relevant MeSH terms:
Caspofungin
Echinocandins
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014