Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

NCT00689338 | Completed Phase 3 Results

• 1 other identifier: A8851019
• Study Type: interventional
• Target: 216
• Locations: 19 countries
• Sites: 61

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.

Conditions

Invasive Candidiasis

Keywords

Candida; Candidemia; Systemic Candidiasis; ICU; Intensive Care Unit; Critical Care Unit; Anidulafungin; Ecalta; Eraxis; Fluconazole; Voriconazole

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Global Treatment Response Success at End of Treatment

  Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

  End of Treatment (Day 14 to Day 56)

Secondary Outcomes (6)

• Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)

  EOIVT (Day 10 up to Day 42)

• Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment

  2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)

• Percentage of Participants With Global Response Success 6 Weeks After End of Treatment

  6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)

• Time to First Negative Blood Culture

  Day 1 up to Day 42

• Day 90 Survival

  Day 90

Study Arms (1)

Treatment Group

EXPERIMENTAL

Option to treat with oral azole therapy following treatment with anidulafungin

Drug: Anidulafungin; Drug: Fluconazole; Drug: Voriconazole

Interventions

Anidulafungin DRUG

Anidulafungin Intravenous Administration

Treatment Group

Fluconazole DRUG

Oral Administration of Fluconazole

Treatment Group

Voriconazole DRUG

Oral Administration of Voriconazole

Treatment Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (61)

Pfizer Investigational Site

Vienna, A-1090, Austria

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Brussels, 1090, Belgium

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Brussels, B-1070, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, B-4000, Belgium

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Yvoir, 5530, Belgium

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Hamilton, Ontario, L8N 3Z5, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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Québec, Quebec, G1R 2J6, Canada

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Brno, 656 91, Czechia

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Ostrava, 708 52, Czechia

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Prague, 100 34, Czechia

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Koebenhavn OE, 2100, Denmark

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Odense C, 5000, Denmark

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Amiens, France, 80054, France

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Bordeaux, France, 33076, France

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Clichy, France, 92110, France

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Lyon, France, 69433, France

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Marseille, France, 13385, France

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Montpellier, France, 34295, France

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Paris, France, 75877, France

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Villejuif, 94804, France

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Berlin, 10117, Germany

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Freiburg im Breisgau, 79106, Germany

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Wuppertal, 42283, Germany

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Kifissia, Athens, 14561, Greece

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Haidari, Attica, 12462, Greece

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Budapest, 1106, Hungary

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Budapest, 1125, Hungary

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Pisa, 56124, Italy

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Roma, 00161, Italy

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Roma, 00168, Italy

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Torino, 10143, Italy

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Udine, 33100, Italy

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Ede, 6716 RP, Netherlands

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Rotterdam, 3083 AN, Netherlands

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Krakow, 31-501, Poland

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Lodz, 90-153, Poland

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Coimbra, 3040-853, Portugal

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Lisbon, 1349-019, Portugal

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Porto, 4200-072, Portugal

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Porto, 4200-319, Portugal

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Iași, Iaşi, 700111, Romania

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Bucharest, 022328, Romania

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Moscow, 115478, Russia

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Moscow, 121552, Russia

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Moscow, 125167, Russia

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Saint Petersburg, 191015, Russia

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Saint Petersburg, 194291, Russia

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Bratislava, 033 10, Slovakia

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Bratislava, 851 07, Slovakia

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Košice, 041 66, Slovakia

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Görükle, Bursa, 16045, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Trabzon, 61080, Turkey (Türkiye)

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Dnipropetrovsk, 49600, Ukraine

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Donetsk, 84003, Ukraine

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Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

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Liverpool, L7 8XP, United Kingdom

Location

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London, SE5 9RS, United Kingdom

Location

Related Publications (4)

• 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

Related Links

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

MeSH Terms

Conditions

Candidiasis, Invasive; Torulopsis; Candidemia; Systemic candidiasis

Interventions

Anidulafungin; Fluconazole; Voriconazole

Condition Hierarchy (Ancestors)

Candidiasis; 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

Limitations and Caveats

In a change to the protocol, time to first negative blood/tissue culture will only concern time to first negative blood culture. Lack of regular tissue sampling meant that analysis of time to first tissue culture could not be meaningfully performed.

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 30, 2011
• Results First Posted: May 17, 2011

Record last verified: 2011-05

Locations

CZ (3); CA (3); GR (2); PT (4); PL (2); RU (5); UA (2); NL (2); FR (8); HU (2); GB (3); DE (3); SL (3); BE (6); TU (3); DK (2); AU (1); IT (5); RO (2)