Clinical trial NCT00689338: Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Invasive Candidiasis
Keywords: Candida
Candidemia
Systemic Candidiasis
ICU
Intensive Care Unit
Critical Care Unit
Anidulafungin
Ecalta
Eraxis
Fluconazole
Voriconazole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Global Treatment Response Success at End of Treatment
timeFrame: End of Treatment (Day 14 to Day 56)
Secondary outcomes:
measure: Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)
timeFrame: EOIVT (Day 10 up to Day 42)
measure: Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment
timeFrame: 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)
measure: Percentage of Participants With Global Response Success 6 Weeks After End of Treatment
timeFrame: 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)
measure: Time to First Negative Blood Culture
timeFrame: Day 1 up to Day 42
measure: Day 90 Survival
timeFrame: Day 90
measure: Time to Successful Intensive Care Unit (ICU) Discharge
timeFrame: Day 1 up to Day 56
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Brussel
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Yvoir
country: Belgium
facility: Pfizer Investigational Site
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 10
country: Czech Republic
facility: Pfizer Investigational Site
city: Koebenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Odense C
country: Denmark
facility: Pfizer Investigational Site
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Clichy
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 18
country: France
facility: Pfizer Investigational Site
city: Villejuif Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Wuppertal
country: Germany
facility: Pfizer Investigational Site
city: Kifisia
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Haidari
country: Greece
facility: Pfizer Investigational Site
state: Attiki
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Ede
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Gorukle
country: Turkey
facility: Pfizer Investigational Site
state: Bursa
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Trabzon
country: Turkey
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
citation: Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
citation: Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
citation: Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.