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

NCT ID: NCT03798600

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2018-12-31

Brief Summary

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.

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.

Conditions

Critical Illness; Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Caspofungin

Intervention Type: 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.

Interventions

Caspofungin

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Careggi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Villa

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianluca Villa, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Careggi

References

Adembri C, Villa G, Rosi E, Tofani L, Fallani S, De Gaudio AR, Novelli A. Caspofungin PK in critically ill patients after the first and fourth doses: suggestions for therapeutic drug monitoring? J Chemother. 2020 May;32(3):124-131. doi: 10.1080/1120009X.2020.1737783. Epub 2020 Mar 23.

Reference Type: DERIVED

PMID: 32202224 (View on PubMed)

Other Identifiers

CEAVC, 32366/2015; OSS.15.114

Identifier Type: -

Identifier Source: org_study_id