Pharmacokinetics of Caspofungin

Completed

• Conditions: Critical Illness; Fungal Infection; Septic Shock
• Interventions: Drug: Caspofungin

• Registration Number: NCT03399032
• Lead Sponsor: Medical University of Lublin

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-07
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-16
• Study Start: 2018-02-05
• Primary Completion: 2018-08-06
• Study Completion: 2018-09-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caspofungin	Caspofungin	Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day

Primary Outcome Measures

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

Trial Locations

Locations (1)

II Department of Anesthesia and Intensive Care, Medical University of Lublin; 🇵🇱 Lublin, Poland