Pharmacokinetics of Caspofungin in Burn Patients (Caspo-brûlés)
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ClinicalTrials.gov Identifier: NCT00748345 |
Recruitment Status
:
Completed
First Posted
: September 8, 2008
Last Update Posted
: December 16, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thermal Injury | Drug: Caspofungin (drug) | Phase 2 Phase 3 |
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 (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 |

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
|
- 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 ]
- mean total clearance [ Time Frame: 18 months ]
- mean distribution volume [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748345
France | |
Cochin | |
Paris, France, 75014 |
Principal Investigator: | Christophe Vinsonneau, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00748345 History of Changes |
Other Study ID Numbers: |
P070601 |
First Posted: | September 8, 2008 Key Record Dates |
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 |