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Pharmacokinetics of Caspofungin in Burn Patients (Caspo-brûlés)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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 Intervention Model: Single Group Assignment Masking: None (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 ]
Secondary Outcome Measures:
- mean total clearance [ Time Frame: 18 months ]
- mean distribution volume [ Time Frame: 12 months ]
| 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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00748345
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 | Assistance Publique - Hôpitaux de Paris |
More Information
| 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 |
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 |
ClinicalTrials.gov processed this record on September 20, 2017