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

NCT00496197 | Completed Phase 4 Results DMC

• 1 other identifier: A8851011
• Study Type: interventional
• Target: 282
• Locations: 2 countries
• Sites: 43

Brief Summary

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.

Conditions

Candidiasis

Keywords

candidemia; invasive candidiasis; fungal bloodstream infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)

  Success: Clinical response=Cure (no signs, symptoms \[s/s\] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up \[f/u\] culture negative) or Presumed Eradication (f/u culture not available \[n/a\] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species \[spp\]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  End of Treatment (Day 5 up to Day 42)

Secondary Outcomes (23)

• Number of Participants With Clinical Response at EOT

  End of Treatment (Day 5 up to Day 42)

• Number of Participants With Microbiological Response at EOT

  End of Treatment (Day 5 up to Day 42)

• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)

  End of Intravenous treatment (Day 5 up to Day 28)

• Number of Participants With Clinical Response at EOIV

  End of Intravenous treatment (Day 5 up to Day 28)

• Number of Participants With Microbiological Response at EOIV

  End of Intravenous treatment (Day 5 up to Day 28)

Study Arms (1)

1.

EXPERIMENTAL

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

Drug: Eraxis (anidulafungin); Drug: Diflucan (fluconazole); Drug: Vfend (voriconazole)

Interventions

Eraxis (anidulafungin) 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.

1.

Diflucan (fluconazole) 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.

1.

Vfend (voriconazole) 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.

1.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (43)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

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Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

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Pfizer Investigational Site

Los Angeles, California, 90033, United States

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Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

San Francisco, California, 94143, United States

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Pfizer Investigational Site

Newark, Delaware, 19713, United States

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Pfizer Investigational Site

Newark, Delaware, 19718, United States

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Pfizer Investigational Site

Wilmington, Delaware, 19801, United States

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Pfizer Investigational Site

Washington D.C., District of Columbia, 20010, United States

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Pfizer Investigational Site

Jacksonville, Florida, 32209, United States

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Pfizer Investigational Site

Miami, Florida, 33136, United States

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Pfizer Investigational Site

Orlando, Florida, 32801, United States

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Pfizer Investigational Site

Orlando, Florida, 32806, United States

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Pfizer Investigational Site

Orlando, Florida, 32819, United States

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Pfizer Investigational Site

Atlanta, Georgia, 30322, United States

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Pfizer Investigational Site

Springfield, Illinois, 62701, United States

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Pfizer Investigational Site

Springfield, Illinois, 62702, United States

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Pfizer Investigational Site

Springfield, Illinois, 62703-9248, United States

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Pfizer Investigational Site

Springfield, Illinois, 62703, United States

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Pfizer Investigational Site

Baltimore, Maryland, 21205, United States

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Pfizer Investigational Site

Baltimore, Maryland, 21287, United States

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Pfizer Investigational Site

Detroit, Michigan, 48201, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202, United States

Location

Pfizer Investigational Site

Royal Oak, Michigan, 48073, United States

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Pfizer Investigational Site

Minneota, Minnesota, 55455, United States

Location

Pfizer Investigational Site

Butte, Montana, 59701, United States

Location

Pfizer Investigational Site

Camden, New Jersey, 08103, United States

Location

Pfizer Investigational Site

Albany, New York, 12208, United States

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Pfizer Investigational Site

Buffalo, New York, 14263, United States

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Pfizer Investigational Site

Rochester, New York, 14642, United States

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Pfizer Investigational Site

Greenville, North Carolina, 27834-6028, United States

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Pfizer Investigational Site

Greenville, North Carolina, 27834, United States

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Pfizer Investigational Site

Portland, Oregon, 97239, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, 19140, United States

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Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

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Pfizer Investigational Site

West Reading, Pennsylvania, 19611, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29414, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Related Publications (5)

• 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.

  PMID: 33891293 DERIVED

• 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.

  PMID: 31280481 DERIVED

• 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.

  PMID: 28597967 DERIVED

• 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.

  PMID: 28459966 DERIVED

• 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.

  PMID: 24559321 DERIVED

Related Links

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

MeSH Terms

Conditions

Candidiasis; Candidemia; Candidiasis, Invasive

Interventions

Anidulafungin; Fluconazole; Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 3, 2011
• Results First Posted: October 3, 2011

Record last verified: 2011-08

Locations

US (39); KR (4)