Pharmacokinetics of Caspofungin

Critical Illness Clinical Trial

Official title:

Pharmacokinetics of Caspofungin in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399032
• Other study ID #: KE-0254/330/2017
• Status: Completed
• Start date: February 5, 2018
• Est. completion date: September 3, 2018

Study information

• Verified date: November 2023
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 3, 2018
• Est. primary completion date: August 6, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Fungal Infection
• Mycoses
• Septic Shock

Intervention

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.

Locations

Country	Name	City	State
Poland	II Department of Anesthesia and Intensive Care, Medical University of Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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