Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization

Careggi Hospital

Status: Completed

Conditions: Infection; Critical Illness

Treatments: Drug: Caspofungin

Study type: Observational

Funder types: Other

Identifiers

NCT03798600

CEAVC, 32366/2015 OSS.15.114;

Details and patient eligibility

About

PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.

Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.

Full description

Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult ICU patients (>18 yrs)
• Severe sepsis or septic shock
• Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).

Exclusion criteria

• Concomitant ciclosporin or rifampicin therapy.
• Pregnancy
• Continuous renal replacement therapy
• Severe Liver failure (Child Pugh score > 6)

Trial design

20 participants in 1 patient group

Critically ill patients

Description:

20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study. Inclusion Criteria: Adult ICU patients (\>18 yrs) with severe sepsis or septic shock undergoing caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy). Exclusion criteria: Concomitant ciclosporin or rifampicin therapy. Pregnancy Continuous renal replacement therapy Severe Liver failure (Child Pugh score \> 6)

Treatment:

Drug: Caspofungin