Pharmacokinetics of Caspofungin in Burn Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Caspofungin; Echinocandins

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