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Completed

NCT Number: NCT03399032

Pharmacokinetics of Caspofungin

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

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Key information

Conditions

Septic Shock Bacterial Infections and Mycoses Critical Illness Disease Attributes Fungal Infection Infections Inflammation Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

II Department of Anesthesia and Intensive Care, Medical University of Lublin

Lublin, 20-081, Poland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caspofungin

Drug

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

Primary outcomes

  1. Serum concentration of caspofungin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Pharmacokinetics of Caspofungin in Critically Ill Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2018
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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