Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization

January 15, 2019 updated by: Gianluca Villa, Careggi Hospital

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

Status

Completed

Intervention / Treatment

Detailed Description

Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gianluca Villa, MD, Azienda Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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