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Completed

NCT Number: 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.

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Key information

Conditions

Critical Illness Disease Attributes Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Caspofungin

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 10, 2019
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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