Pharmacokinetics of Caspofungin

Pharmacokinetics of Caspofungin in Critically Ill Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03399032

Enrollment

Registered

2018-01-16

Start date

2018-02-05

Completion date

2018-09-03

Last updated

2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Fungal Infection, Septic Shock

Keywords

caspofungin, pharmacokinetics

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.

Interventions

DRUGCaspofungin

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026