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Completed

NCT Number: NCT01047267

Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Critical Illness Critically Ill Disease Attributes Infections Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

About this study

One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.

For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • treatment with anidulafungin
  • at least 18 years of age
  • invasive candidiasis
  • admitted to an intensive care unit

Exclusion criteria

  • allergic to anidulafungin or its excipients
  • contra-indication stated in SPC
  • neutropenia

Treatment and study plan

Primary outcomes

  1. To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels.

    Time frame: 3 days

Secondary outcomes

  1. Time (in days) to culture conversion

    Time frame: max 28 days

  2. Response to treatment at day 28

    Time frame: 28 days

  3. Mortality at day 28 due to fungal infection and overall mortality at 28 days

    Time frame: 28 days

  4. AUC/MIC ratio, time above MIC

    Time frame: max 28 days

  5. Composing a pharmacokinetic model of anidulafungin in critically ill patients

    Time frame: max 28 days

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Apr 6, 2012

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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