Clinical trial NCT00806351: An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
Official title: Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Fungemia
Neutropenia
Candidiasis
Keywords: Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.


Eligibility criteria: Inclusion Criteria:

* Dysfunctional immune system (reduced neutrophils).
* Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
* Male of female ≥16 years of age.
* Expected hospitalization for at least ten (10) days.

Exclusion Criteria:

* Pregnancy or breast feeding or planning to become pregnant during the study.
* Recent treatment with one of the study drugs over the last 30 days.
* Allergy to either study drug or to this class of drugs.
* Significant liver dysfunction.
* Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Primary outcomes:
measure: Global Response at End of Intravenous Treatment (EOIVT)
timeFrame: Day 10 up to Day 42
Secondary outcomes:
measure: Global Response at End of Treatment (EOT)
timeFrame: Day 14 up to Day 56
measure: Global Response at 2-Week Follow-Up Visit
timeFrame: 2 weeks post treatment
measure: Global Response at 6-Week Follow-Up Visit
timeFrame: 6 weeks post treatment
measure: Response Based on Clinical Cure and Microbiological Success at EOIVT
timeFrame: Day 10 up to Day 42
measure: Response Based on Clinical Cure and Microbiological Success at EOT
timeFrame: Day 14 up to Day 56
measure: Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit
timeFrame: 2 weeks post treatment
measure: Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit
timeFrame: 6 weeks post treatment
measure: Clinical Response at Day 10
timeFrame: Day 10
measure: Number of Participants With Recurrence
timeFrame: 2 and 6 weeks post treatment
measure: Number of Participants With New Infections
timeFrame: 2 and 6 weeks post treatment
measure: Time to First Negative Blood Culture for Candida Species
timeFrame: Baseline up to Day 56
measure: Time to Death
timeFrame: Day 1 up to Day 98
measure: All-Cause Mortality
timeFrame: Baseline up to 6 weeks post treatment
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: Pfizer Investigational Site
city: GRENOBLE Cedex 09
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
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: 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.