Pharmacokinetics of Caspofungin

Study Overview
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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.

Official Title
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Pharmacokinetics of Caspofungin in Critically Ill Patients

Conditions
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Septic Shock, Fungal Infection, Critical Illness

Intervention / Treatment
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* Drug: Caspofungin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caspofungin<br>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<br>* 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.<br>* Other names: blood collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caspofungin, pharmacokinetics