Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates

NCT01533558 | Completed

• 1 other identifier: AKF UMCN 11.02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard care. Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be taken daily.

Conditions

Invasive Fungal Infection

Keywords

caspofungin; pharmacokinetics; invasive fungal infection; candidiasis; aspergillosis; intensive care

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC)

  AUC0-tau, AUC0-inf (Time Frame: predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose on Day 3 and predose, 1, 4, 8, 12 hours + 6 days after the dose on Day 7) of caspofungin

  day 3 and day 7

Secondary Outcomes (2)

• co-variates influencing PK of caspofungin

  day 3 and day 7

• Number of Participants with Adverse Events

  14 days

Study Arms (1)

caspofungin

caspofungin dosing

Drug: caspofungin

Interventions

caspofungin DRUG

normal dosage for caspofungin, not adapted for the study

Also known as: Cancidas

caspofungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

intensive care patients with invasive fungal infection

You may qualify if:

• Patient is admitted to an ICU
• Subject is at least 18 and not older than 65 years of age on the day of the first dosing
• Subject has been treated with caspofungin for a maximum of two days before enrolment in this trial
• Is managed with a central venous catheter

You may not qualify if:

• Is known to be hypersensitive to echinocandin antifungal agents
• Documented history of sensitivity to medicinal products or excipients similar to those found in the caspofungin preparation
• Positive HIV test or hepatitis B or C test
• History of QT time prolongation
• History of or current abuse of drugs, alcohol or solvents
• Has previously participated in this trial

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (4)

Rijnstate Hospital

Arnhem, Netherlands

Location

Canisius Wilhelmina Hospital (CWZ)

Nijmegen, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• Muilwijk EW, Schouten JA, van Leeuwen HJ, van Zanten AR, de Lange DW, Colbers A, Verweij PE, Burger DM, Pickkers P, Bruggemann RJ. Pharmacokinetics of caspofungin in ICU patients. J Antimicrob Chemother. 2014 Dec;69(12):3294-9. doi: 10.1093/jac/dku313. Epub 2014 Aug 19.

  PMID: 25139840 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples for determination of caspofungin

MeSH Terms

Conditions

Invasive Fungal Infections; Candidiasis; Aspergillosis

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Roger Brüggemann, PhD, PharmD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 15, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

NL (4)