Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

Invasive Candidiasis Clinical Trial

— ICE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689338
• Other study ID #: A8851019
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2008
• Last updated: May 25, 2011
• Start date: July 2008
• Est. completion date: May 2010

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Intervention

Drug:
• Anidulafungin
Anidulafungin Intravenous Administration
• Fluconazole
Oral Administration of Fluconazole
• Voriconazole
Oral Administration of Voriconazole

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Brussel
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Liege
Belgium	Pfizer Investigational Site	Yvoir
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Quebec
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Ostrava
Czech Republic	Pfizer Investigational Site	Praha 10
Denmark	Pfizer Investigational Site	Koebenhavn OE
Denmark	Pfizer Investigational Site	Odense C
France	Pfizer Investigational Site	Amiens
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Clichy
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Paris Cedex 18
France	Pfizer Investigational Site	Villejuif Cedex
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Wuppertal
Greece	Pfizer Investigational Site	Haidari	Attiki
Greece	Pfizer Investigational Site	Kifisia	Athens
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Torino
Italy	Pfizer Investigational Site	Udine
Netherlands	Pfizer Investigational Site	Ede
Netherlands	Pfizer Investigational Site	Rotterdam
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Lodz
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Porto
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Iasi
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Gorukle	Bursa
Turkey	Pfizer Investigational Site	Trabzon
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
United Kingdom	Pfizer Investigational Site	Leeds	West Yorkshire
United Kingdom	Pfizer Investigational Site	Liverpool
United Kingdom	Pfizer Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Global Treatment Response Success at End of Treatment	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).	End of Treatment (Day 14 to Day 56)	No
Secondary	Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)	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).	EOIVT (Day 10 up to Day 42)	No
Secondary	Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment	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 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)	No
Secondary	Percentage of Participants With Global Response Success 6 Weeks After End of Treatment	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).	6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)	No
Secondary	Time to First Negative Blood Culture	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.	Day 1 up to Day 42	No
Secondary	Day 90 Survival	Percentage of participants known or assumed to be alive on Day 90.	Day 90	No
Secondary	Time to Successful Intensive Care Unit (ICU) Discharge	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.	Day 1 up to Day 56	No

External Links

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