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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798600
• Other study ID #: CEAVC, 32366/2015; OSS.15.114
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Infection

Intervention

Drug:
• Caspofungin
In accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people < 80 kg body weight). No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Careggi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.	first 24 hours after loading dose
Secondary	Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin	The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.	first 24 hours after loading dose
Secondary	Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin	The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.	at day 4 after loading dose
Secondary	Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin	The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.	first 24 hours after loading dose
Secondary	Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin	The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.	at day 4 after loading dose
Secondary	Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.	first 24 hours after loading dose
Secondary	Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.	at day 4 after loading dose
Secondary	Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.	first 24 hours after loading dose
Secondary	Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.	at day 4 after loading dose
Secondary	Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.	first 24 hours after loading dose
Secondary	Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.	at day 4 after loading dose
Secondary	Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.	first 24 hours after loading dose
Secondary	Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.	at day 4 after loading dose
Secondary	Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).	The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.	at day 4 after loading dose