- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03798600
Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization
PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.
Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult ICU patients (>18 yrs)
- Severe sepsis or septic shock
- Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).
Exclusion Criteria:
- Concomitant ciclosporin or rifampicin therapy.
- Pregnancy
- Continuous renal replacement therapy
- Severe Liver failure (Child Pugh score > 6)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Critically ill patients
20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study. Inclusion Criteria: Adult ICU patients (>18 yrs) with severe sepsis or septic shock undergoing caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy). Exclusion criteria: Concomitant ciclosporin or rifampicin therapy. Pregnancy Continuous renal replacement therapy Severe Liver failure (Child Pugh score > 6) |
In accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people < 80 kg body weight).
No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: first 24 hours after loading dose
|
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
|
first 24 hours after loading dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time Frame: first 24 hours after loading dose
|
The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
|
first 24 hours after loading dose
|
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time Frame: at day 4 after loading dose
|
The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
|
at day 4 after loading dose
|
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time Frame: first 24 hours after loading dose
|
The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
|
first 24 hours after loading dose
|
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time Frame: at day 4 after loading dose
|
The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
|
at day 4 after loading dose
|
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: first 24 hours after loading dose
|
The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
|
first 24 hours after loading dose
|
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: at day 4 after loading dose
|
The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
|
at day 4 after loading dose
|
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: first 24 hours after loading dose
|
The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
|
first 24 hours after loading dose
|
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: at day 4 after loading dose
|
The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
|
at day 4 after loading dose
|
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: first 24 hours after loading dose
|
The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.
|
first 24 hours after loading dose
|
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: at day 4 after loading dose
|
The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.
|
at day 4 after loading dose
|
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: first 24 hours after loading dose
|
The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.
|
first 24 hours after loading dose
|
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: at day 4 after loading dose
|
The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.
|
at day 4 after loading dose
|
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame: at day 4 after loading dose
|
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
|
at day 4 after loading dose
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gianluca Villa, MD, Azienda Careggi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- CEAVC, 32366/2015; OSS.15.114
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
product manufactured in and exported from the U.S.
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