Pharmacokinetics of Caspofungin in Burn Patients

NCT00748345 | Completed Phase 2 DMC

• 1 other identifier: P070601
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thermal Injury

Keywords

Caspofungin,; burn patients,; pharmacokinetics,; optimal dose,; antifungal treatment

Outcome Measures

Primary Outcomes (1)

• area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing)

  18 months

Secondary Outcomes (2)

• mean total clearance

  18 months

• mean distribution volume

  12 months

Study Arms (1)

1

EXPERIMENTAL

Caspofungin (drug)

Drug: Caspofungin (drug)

Interventions

Caspofungin (drug) 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

Also known as: pharmacokinetics of caspofungin in burn patients

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• survival inferior to 5 days
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin

Paris, 75014, France

Location

Related Publications (1)

• Jullien V, Blanchet B, Benyamina M, Tod M, Vinsonneau C. Pharmacokinetics of caspofungin in two patients with burn injuries. Antimicrob Agents Chemother. 2012 Aug;56(8):4550-1. doi: 10.1128/AAC.00039-12. Epub 2012 May 14. No abstract available.

  PMID: 22585216 RESULT

MeSH Terms

Interventions

Caspofungin; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Christophe Vinsonneau, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: September 8, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

FR (1)