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Pharmacokinetics of Caspofungin

NCT ID: NCT03399032

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-09-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Septic Shock Fungal Infection Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Caspofungin

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

Caspofungin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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blood collection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Michał Borys

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Lublin, , Poland

Site Status

Countries

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Poland

References

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Borsuk-De Moor A, Sysiak-Slawecka J, Rypulak E, Borys M, Piwowarczyk P, Raszewski G, Onichimowski D, Czuczwar M, Wiczling P. Nonstationary Pharmacokinetics of Caspofungin in ICU Patients. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00345-20. doi: 10.1128/AAC.00345-20. Print 2020 Aug 20.

Reference Type DERIVED
PMID: 32601169 (View on PubMed)

Other Identifiers

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KE-0254/330/2017

Identifier Type: -

Identifier Source: org_study_id