Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

Condition(s) targeted: Candida; Candidiasis

Intervention: Anidulafungin (Drug); Fluconazole (Drug); Voriconazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy endpoint will be the global treatment response at the End of Treatment.

Secondary outcome:

Global response at the End of Intra Venous Treatment, at 2 weeks after End of Treatment and at 6 weeks after End of Treatment.

Time to first negative blood/tissue culture (defined as first negative culture which is not followed by positive culture within the next 3 days).

Day 90 survival

Time to ICU discharge.

Incidence of adverse events and discontinuation from study treatment.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Wien A-1090, Austria; Recruiting

Pfizer Investigational Site, Liege B-4000, Belgium; Recruiting

Pfizer Investigational Site, Leuven 3000, Belgium; Recruiting

Pfizer Investigational Site, Brussel 1090, Belgium; Recruiting

Pfizer Investigational Site, Brussels B-1070, Belgium; Recruiting

Pfizer Investigational Site, Gent 9000, Belgium; Recruiting

Pfizer Investigational Site, Yvoir 5530, Belgium; Recruiting

Pfizer Investigational Site, Quebec G1R 2J6, Canada; Recruiting

Pfizer Investigational Site, Praha 5 150 06, Czech Republic; Not yet recruiting

Pfizer Investigational Site, Ostrava 708 52, Czech Republic; Recruiting

Pfizer Investigational Site, Praha 10 100 34, Czech Republic; Recruiting

Pfizer Investigational Site, Brno 656 91, Czech Republic; Recruiting

Pfizer Investigational Site, Plzen-Lochotin 304 60, Czech Republic; Not yet recruiting

Pfizer Investigational Site, Koebenhavn OE 2100, Denmark; Recruiting

Pfizer Investigational Site, Odense C 5000, Denmark; Recruiting

Pfizer Investigational Site, LYON 69433, France; Recruiting

Pfizer Investigational Site, Bordeaux 33076, France; Recruiting

Pfizer Investigational Site, MARSEILLE 13385, France; Recruiting

Pfizer Investigational Site, Amiens 80054, France; Recruiting

Pfizer Investigational Site, VILLEJUIF CEDEX 94804, France; Recruiting

Pfizer Investigational Site, PARIS CEDEX 18 75877, France; Recruiting

Pfizer Investigational Site, Montpellier 34295, France; Active, not recruiting

Pfizer Investigational Site, CLICHY 92110, France; Recruiting

Pfizer Investigational Site, Strasbourg 67200, France; Not yet recruiting

Pfizer Investigational Site, Luebeck 23538, Germany; Not yet recruiting

Pfizer Investigational Site, Wuppertal 42283, Germany; Recruiting

Pfizer Investigational Site, Aachen 52074, Germany; Not yet recruiting

Pfizer Investigational Site, Homburg/Saar 66421, Germany; Not yet recruiting

Pfizer Investigational Site, Frankfurt 60596, Germany; Not yet recruiting

Pfizer Investigational Site, Berlin 10117, Germany; Recruiting

Pfizer Investigational Site, Freiburg 79106, Germany; Recruiting

Pfizer Investigational Site, Budapest 1125, Hungary; Recruiting

Pfizer Investigational Site, Budapest 1106, Hungary; Recruiting

Pfizer Investigational Site, Debrecen 4043, Hungary; Not yet recruiting

Pfizer Investigational Site, Roma 00168, Italy; Recruiting

Pfizer Investigational Site, Roma 00161, Italy; Recruiting

Pfizer Investigational Site, Udine 33100, Italy; Recruiting

Pfizer Investigational Site, Pisa 56124, Italy; Recruiting

Pfizer Investigational Site, Torino 10143, Italy; Terminated

Pfizer Investigational Site, Rotterdam 3015 CE, Netherlands; Not yet recruiting

Pfizer Investigational Site, Ede 6716 RP, Netherlands; Recruiting

Pfizer Investigational Site, Rotterdam 3083 AN, Netherlands; Not yet recruiting

Pfizer Investigational Site, Wroclaw 50-368, Poland; Not yet recruiting

Pfizer Investigational Site, Krakow 31-501, Poland; Recruiting

Pfizer Investigational Site, Katowice 40-752, Poland; Not yet recruiting

Pfizer Investigational Site, Lodz 90-153, Poland; Recruiting

Pfizer Investigational Site, Porto 4200-319, Portugal; Recruiting

Pfizer Investigational Site, Porto 4200-072, Portugal; Recruiting

Pfizer Investigational Site, Lisboa 1349-019, Portugal; Recruiting

Pfizer Investigational Site, Coimbra 3040-853, Portugal; Recruiting

Pfizer Investigational Site, Bucuresti 022328, Romania; Recruiting

Pfizer Investigational Site, Iasi 700111, Romania; Recruiting

Pfizer Investigational Site, Moscow 121552, Russian Federation; Recruiting

Pfizer Investigational Site, Saint-Petersburg 191015, Russian Federation; Recruiting

Pfizer Investigational Site, Saint-Petersburg 194291, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 125167, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 115478, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 115446, Russian Federation; Not yet recruiting

Pfizer Investigational Site, Bratislava 033 10, Slovakia; Recruiting

Pfizer Investigational Site, Bratislava 851 07, Slovakia; Recruiting

Pfizer Investigational Site, Kosice 041 90, Slovakia; Not yet recruiting

Pfizer Investigational Site, Kosice 041 66, Slovakia; Recruiting

Pfizer Investigational Site, Ankara 06100, Turkey; Recruiting

Pfizer Investigational Site, Trabzon 61080, Turkey; Not yet recruiting

Pfizer Investigational Site, Donetsk 84003, Ukraine; Recruiting

Pfizer Investigational Site, Dnipropetrovsk 49600, Ukraine; Recruiting

Pfizer Investigational Site, Kharkiv 61037, Ukraine; Not yet recruiting

Pfizer Investigational Site, Liverpool L7 8XP, United Kingdom; Recruiting

Pfizer Investigational Site, Coventry CV2 2DX, United Kingdom; Not yet recruiting

Pfizer Investigational Site, London SE5 9RS, United Kingdom; Recruiting

Pfizer Investigational Site, Leeds LS9 7TF, United Kingdom; Not yet recruiting

Pfizer Investigational Site, Kifisia, Athens 14561, Greece; Recruiting

Pfizer Investigational Site, Haidari, Attiki 12462, Greece; Recruiting

Pfizer Investigational Site, Reading, Berkshire RG1 5AN, United Kingdom; Recruiting

Pfizer Investigational Site, Gorukle, Bursa 16045, Turkey; Recruiting

Pfizer Investigational Site, Altunizade, Istanbul, Turkey; Not yet recruiting

Pfizer Investigational Site, Hamilton, Ontario L8N 3Z5, Canada; Recruiting

Pfizer Investigational Site, Hamilton, Ontario L8N 4A6, Canada; Recruiting

Pfizer Investigational Site, Montreal, Quebec H1T 2M4, Canada; Not yet recruiting

Pfizer Investigational Site, Montréal, Quebec H2W 1T8, Canada; Not yet recruiting

Pfizer Investigational Site, BUCURESTI, Sector 5 050098, Romania; Not yet recruiting

Pfizer Investigational Site, Leeds, West Yorkshire LS1 3EX, United Kingdom; Recruiting

Pfizer Investigational Site, Bucuresti, sector2 021105, Romania; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: July 2008
Ending date: May 2010
Last updated: October 16, 2009