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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR ERAXIS

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Clinical Trials for Eraxis

Trial ID Title Status Sponsor Phase Summary
NCT00496197 Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis Completed Pfizer Phase 4 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.
NCT00531479 Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis Completed Pfizer Phase 3 This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.
NCT00548262 This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis Completed Pfizer Phase 4 The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.
NCT00620074 Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene) Terminated Pfizer Phase 4 This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.
NCT00672841 β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients Completed Pfizer N/A This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
NCT00672841 β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients Completed Duke University N/A This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
NCT00734500 Anidulafungin PK in Infants and Toddlers Completed Michael Cohen-Wolkowiez Phase 1 This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Eraxis

Condition Name

Condition Name for Eraxis
Intervention Trials
Candidiasis 3
Fungemia 3
Mycoses 2
Candidemia 2
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Condition MeSH

Condition MeSH for Eraxis
Intervention Trials
Candidiasis 6
Candidiasis, Invasive 4
Fungemia 3
Mycoses 3
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Clinical Trial Locations for Eraxis

Trials by Country

Trials by Country for Eraxis
Location Trials
United States 55
Brazil 11
Canada 6
Russian Federation 5
France 4
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Trials by US State

Trials by US State for Eraxis
Location Trials
Texas 5
North Carolina 5
Michigan 5
Pennsylvania 4
Florida 4
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Clinical Trial Progress for Eraxis

Clinical Trial Phase

Clinical Trial Phase for Eraxis
Clinical Trial Phase Trials
Phase 4 5
Phase 3 4
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Eraxis
Clinical Trial Phase Trials
Completed 7
Terminated 3
Recruiting 1
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Clinical Trial Sponsors for Eraxis

Sponsor Name

Sponsor Name for Eraxis
Sponsor Trials
Pfizer 8
University of Texas Southwestern Medical Center 1
National Center for Research Resources (NCRR) 1
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Sponsor Type

Sponsor Type for Eraxis
Sponsor Trials
Industry 8
Other 5
NIH 1
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