Skip to main content
OpenTrials
Completed

NCT Number: NCT00689338

Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Systemic candidiasis Torulopsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

  • Post-abdominal surgery.
  • Elderly > 65 years old.
  • Renal insufficiency / failure / hemodialysis.
  • Solid tumor.
  • Solid-organ (liver, kidney, lung, heart) transplant recipients.
  • Hepatic insufficiency.
  • Neutropenic including hematology oncology patients.

Exclusion criteria

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

Treatment and study plan

Anidulafungin

Drug

Anidulafungin Intravenous Administration

Fluconazole

Drug

Oral Administration of Fluconazole

Voriconazole

Drug

Oral Administration of Voriconazole

Primary outcomes

  1. Percentage of Participants With Global Treatment Response Success at End of Treatment

    Time frame: End of Treatment (Day 14 to Day 56)

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

Secondary outcomes

  1. Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)

    Time frame: EOIVT (Day 10 up to Day 42)

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

  2. Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment

    Time frame: 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

  3. Percentage of Participants With Global Response Success 6 Weeks After End of Treatment

    Time frame: 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

  4. Time to First Negative Blood Culture

    Time frame: Day 1 up to Day 42

    Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.

  5. Day 90 Survival

    Time frame: Day 90

    Percentage of participants known or assumed to be alive on Day 90.

  6. Time to Successful Intensive Care Unit (ICU) Discharge

    Time frame: Day 1 up to Day 56

    Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations

Acronym: ICE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2008
Registry last updated
May 30, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.