Pharmacokinetics of Caspofungin

Pharmacokinetics of Caspofungin in Critically Ill Patients

The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Septic Shock; Fungal Infection
• Intervention / Treatment: Drug: Caspofungin

Detailed Description

This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily.

Blood samples (3 mL) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. The standard arterial canula will be used to obtain samples.

30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum caspofungin concentration will be measured with high performance liquid chromatography.

Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical patients will be included. Any site of infection will be treated in the manner.

Description

Inclusion Criteria:

• Patients who require ICU treatment due to severe sepsis age
• 18-80 years
• an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria:

• allergy to caspofungin
• lack of consent to participate in the study
• age of patients below 18 or above 80 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Caspofungin; Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day	Drug: Caspofungin; Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day Blood samples (3 mL) will be collected 2, 4, 8, 12 and 24 hours after each dose of caspofungin for 3 consecutive days.; Other Names: blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of caspofungin	Samples obtain from ICU patients 2, 4, 8 12 and 24hours after each dose of caspofungin for 3 days.	72 hours for each patient from the tigecycline treatment initiation

Collaborators and Investigators

• Sponsor: Medical University of Lublin

Publications and helpful links

General Publications

• Borsuk-De Moor A, Sysiak-Slawecka J, Rypulak E, Borys M, Piwowarczyk P, Raszewski G, Onichimowski D, Czuczwar M, Wiczling P. Nonstationary Pharmacokinetics of Caspofungin in ICU Patients. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00345-20. doi: 10.1128/AAC.00345-20. Print 2020 Aug 20.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 5, 2018
• Primary Completion (Anticipated): August 6, 2018
• Study Completion (Anticipated): September 3, 2018

Study Registration Dates

• First Submitted: January 7, 2018
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 7, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: pharmacokinetics; caspofungin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Critical Illness; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Caspofungin
• Other Study ID Numbers: KE-0254/330/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No