Pharmacokinetics of Caspofungin in Burn Patients

Thermal Injury Clinical Trial

— Caspo-brûlés  

Official title:

Pharmacokinetics of Caspofungin in Burn Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748345
• Other study ID #: P070601
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 31, 2008
• Last updated: December 15, 2011
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thermal Injury

Intervention

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

Locations

Country	Name	City	State
France	Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing)		18 months	Yes
Secondary	mean total clearance		18 months	Yes
Secondary	mean distribution volume		12 months	Yes