- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03399032
Pharmacokinetics of Caspofungin
Pharmacokinetics of Caspofungin in Critically Ill Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Michał Borys, M.D., PhD
- Phone Number: +48 506350569
- Email: michalborys1@gmail.com
Study Contact Backup
- Name: Mirosław Czuczwar, M.D., PhD
- Phone Number: +48 509390985
- Email: czuczwarm@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
72 hours for each patient from the tigecycline treatment initiation
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KE-0254/330/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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