Pharmacokinetics of Caspofungin

Sponsor
Medical University of Lublin (Other)
Overall Status
Unknown status
CT.gov ID
NCT03399032
Collaborator
(none)
30
6.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pharmacokinetics of Caspofungin in Critically Ill Patients
Anticipated Study Start Date :
Feb 5, 2018
Anticipated Primary Completion Date :
Aug 6, 2018
Anticipated Study Completion Date :
Sep 3, 2018

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical University of Lublin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michał Borys, associate professor, Medical University of Lublin
    ClinicalTrials.gov Identifier:
    NCT03399032
    Other Study ID Numbers:
    • KE-0254/330/2017
    First Posted:
    Jan 16, 2018
    Last Update Posted:
    Jan 16, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michał Borys, associate professor, Medical University of Lublin
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 16, 2018