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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03399032
Other study ID # KE-0254/330/2017
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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