Pharmacokinetics of Caspofungin

NCT03399032 | Completed

• 1 other identifier: KE-0254/330/2017
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.

Conditions

Septic Shock; Fungal Infection; Critical Illness

Keywords

caspofungin; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Caspofungin

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

Interventions

Caspofungin DRUG

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.

Also known as: blood collection

Caspofungin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical patients will be included. Any site of infection will be treated in the manner.

You may qualify if:

• Patients who require ICU treatment due to severe sepsis age
• years
• an eligible consent obtained from the patient or his/her attendant

You may not qualify if:

• allergy to caspofungin
• lack of consent to participate in the study
• age of patients below 18 or above 80 years

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

II Department of Anesthesia and Intensive Care, Medical University of Lublin

Lublin, 20-081, Poland

Location

Related Publications (1)

• Borsuk-De Moor A, Sysiak-Slawecka J, Rypulak E, Borys M, Piwowarczyk P, Raszewski G, Onichimowski D, Czuczwar M, Wiczling P. Nonstationary Pharmacokinetics of Caspofungin in ICU Patients. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00345-20. doi: 10.1128/AAC.00345-20. Print 2020 Aug 20.

  PMID: 32601169 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients' arterial blood samples.

MeSH Terms

Conditions

Shock, Septic; Mycoses; Critical Illness

Interventions

Caspofungin; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Bacterial Infections and Mycoses; Disease Attributes

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 7, 2018
• First Posted: January 16, 2018
• Study Start: February 5, 2018
• Primary Completion: August 6, 2018
• Study Completion: September 3, 2018
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)