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Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

NCT ID: NCT00496197

Last Updated: 2011-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.

Detailed Description

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Conditions

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Candidiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.

Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.

Group Type EXPERIMENTAL

Eraxis (anidulafungin)

Intervention Type DRUG

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Diflucan (fluconazole)

Intervention Type DRUG

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.

Vfend (voriconazole)

Intervention Type DRUG

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Interventions

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Eraxis (anidulafungin)

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Intervention Type DRUG

Diflucan (fluconazole)

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.

Intervention Type DRUG

Vfend (voriconazole)

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects \> or equal to 18 years of age.
* Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
* Subjects who received no more than one prior dose of an echinocandin or polyene.

Exclusion Criteria

* Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
* Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
* Subjects with infected prosthetic devices which cannot be removed within 24 hours
Minimum Eligible Age

18 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

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

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Pfizer Investigational Site

Little Rock, Arkansas, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

San Francisco, California, United States

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San Francisco, California, United States

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Newark, Delaware, United States

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Pfizer Investigational Site

Newark, Delaware, United States

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Pfizer Investigational Site

Wilmington, Delaware, United States

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Pfizer Investigational Site

Washington D.C., District of Columbia, United States

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Pfizer Investigational Site

Jacksonville, Florida, United States

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Pfizer Investigational Site

Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Pfizer Investigational Site

Springfield, Illinois, United States

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Springfield, Illinois, United States

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Springfield, Illinois, United States

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Springfield, Illinois, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Royal Oak, Michigan, United States

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Minneota, Minnesota, United States

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Butte, Montana, United States

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Camden, New Jersey, United States

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Albany, New York, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Greenville, North Carolina, United States

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Pfizer Investigational Site

Greenville, North Carolina, United States

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Portland, Oregon, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pfizer Investigational Site

West Reading, Pennsylvania, United States

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Pfizer Investigational Site

Charleston, South Carolina, United States

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Pfizer Investigational Site

Houston, Texas, United States

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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United States South Korea

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)

Vazquez J, Reboli AC, Pappas PG, Patterson TF, Reinhardt J, Chin-Hong P, Tobin E, Kett DH, Biswas P, Swanson R. Evaluation of an early step-down strategy from intravenous anidulafungin to oral azole therapy for the treatment of candidemia and other forms of invasive candidiasis: results from an open-label trial. BMC Infect Dis. 2014 Feb 21;14:97. doi: 10.1186/1471-2334-14-97.

Reference Type DERIVED
PMID: 24559321 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851011&StudyName=Study%20Will%20Evaluate%20The%20Safety%20And%20Efficacy%20Of%20Anidulafungin%20In%20Patients%20With%20Candidemia%20Or%20Invasive%20Candidiasis

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

Other Identifiers

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A8851011

Identifier Type: -

Identifier Source: org_study_id