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An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

NCT ID: NCT00805740

Last Updated: 2013-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Detailed Description

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Conditions

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Candidiasis Fungemia

Keywords

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Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anidulafungin arm

Group Type EXPERIMENTAL

Active anidulafungin

Intervention Type DRUG

Subjects in this arm will receive active anidulafungin and placebo caspofungin

Caspofungin arm

Group Type EXPERIMENTAL

Active Caspofungin

Intervention Type DRUG

Subjects in this arm will receive active caspofungin and placebo anidulafungin

Interventions

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Active anidulafungin

Subjects in this arm will receive active anidulafungin and placebo caspofungin

Intervention Type DRUG

Active Caspofungin

Subjects in this arm will receive active caspofungin and placebo anidulafungin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection.
* Male or female ≥ 16 years of age.
* Expected hospitalization for at least fourteen (14) 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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Newark, Delaware, United States

Site Status

Pfizer Investigational Site

Newark, Delaware, United States

Site Status

Pfizer Investigational Site

Wilmington, Delaware, United States

Site Status

Pfizer Investigational Site

Detroit, Michigan, United States

Site Status

Pfizer Investigational Site

Antwerp, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Sofia, , Bulgaria

Site Status

Pfizer Investigational Site

Vancouver, British Columbia, Canada

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Nijmegen, , Netherlands

Site Status

Pfizer Investigational Site

Coimbra, , Portugal

Site Status

Pfizer Investigational Site

Lisbon, , Portugal

Site Status

Pfizer Investigational Site

Bucharest, , Romania

Site Status

Pfizer Investigational Site

P/o Stepanovskoe, Krasnogorskiy District, Moscow Region, , Russia

Site Status

Pfizer Investigational Site

Geneva, , Switzerland

Site Status

Countries

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Croatia United States Belgium Bulgaria Canada Netherlands Portugal Romania Russia Switzerland

References

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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.

Reference Type DERIVED
PMID: 33891293 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31280481 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28597967 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28459966 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851022&StudyName=An%20Evaluation%20Of%20The%20Effectiveness%20And%20Safety%20Of%20Anidulafungin%20Compared%20To%20Caspofungin%20For%20The%20Treatment%20Of%20Deep%20Tissue%20Infection%20Due%20

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Other Identifiers

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A8851022

Identifier Type: -

Identifier Source: org_study_id