NCT01438216

Brief Summary

The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 22, 2011

Status Verified

September 1, 2011

Enrollment Period

5 months

First QC Date

September 14, 2011

Last Update Submit

September 19, 2011

Conditions

Invasive CandidiasisCandidemia

Keywords

PharmacokineticsIntensive CareCandidemiaInvasive candidiasisAnidulafungin

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic population model for anidulafungin for the ICU population

    The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model.

    1 year, after inclusion of 20 patients

Secondary Outcomes (5)

  • Time until clinical and microbiological response is reached

    1 year, after inclusion of 20 patients

  • To determine the covariates that influence the kinetics of anidulafungin.

    1 year, after inclusion of 20 patients

  • To determine the optimal dosage(scheme) for intensive care patients.

    1 year, after inclusion of 20 patients

  • To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC.

    1 year, after inclusion of 20 patients

  • Registration of side effects and adverse events

    1 year, after inclusion of 20 patients

Study Arms (2)

VUmc IC

Due to multicentre, 2 groups of patient in 1 cohort

UMCN IC

Due to multicentre, 2 groups of patient in 1 cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive Care patients

You may qualify if:

  • Patient is admitted to the intensive care unit
  • Patient has a central (venous) infusion line
  • Patient is at least 18 years old
  • Patient receives treatment with anidulafungin
  • that is initiated on the ICU or
  • that is continued on the ICU and the patient has had no more than 2 days of treatment with anidulafungin

You may not qualify if:

  • Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
  • Patient receives treatment with anidulafungin that is continued on the ICU and the patient has had 3 or more days of treatment with anidulafungin
  • A woman that is pregnant, wanting to become pregnant or nursing an infant
  • \< 48 hours (expected) treatment with anidulafungin on the ICU ward
  • Has previously participated in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Related Publications (1)

  • Bruggemann RJ, Middel-Baars V, de Lange DW, Colbers A, Girbes AR, Pickkers P, Swart EL. Pharmacokinetics of Anidulafungin in Critically Ill Intensive Care Unit Patients with Suspected or Proven Invasive Fungal Infections. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01894-16. doi: 10.1128/AAC.01894-16. Print 2017 Feb.

    PMID: 27872072DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Candidiasis, InvasiveCandidemia

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vera M Middel-Baars, PharmD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • Eleonora L Swart, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • Roger Brüggemann, PharmD

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera M Middel-Baars, PharmD

CONTACT

+31 20 4445282v.middel-baars@vumc.nl

Eleonora L. Swart, PhD

CONTACT

+31 20 4443524el.swart@vumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD, hospital pharmacist trainee

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 22, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

September 22, 2011

Record last verified: 2011-09

Locations

NL(2)