An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
NCT ID: NCT03604705
Last Updated: 2025-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2018-10-03
2020-07-02
Brief Summary
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Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks.
This study will be conducted at approximately 20 sites in the United States and globally.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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APX001 Treatment
APX001
APX001
Interventions
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APX001
APX001
Eligibility Criteria
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Inclusion Criteria
* Adults ages 18 and above male or female
* New diagnosis of candidemia
* Able to have pre-existing intravascular catheters removed and replaced (as necessary)
Exclusion Criteria
* deep-seated Candida-related infections
* hepatosplenic candidiasis
* received more than 2 days of prior systemic antifungal treatment for current candidemia episode
* severe hepatic impairment
18 Years
ALL
No
Sponsors
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Basilea Pharmaceutica
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Engelhardt
Role: STUDY_DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Locations
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University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
University of California, Davis
Davis, California, United States
University of California-Davis Medical Center
Sacramento, California, United States
Augusta University (Georgia Regents University)
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Washington University
St Louis, Missouri, United States
Duke University Hospital Medical Center
Durham, North Carolina, United States
University of Texas- Health Science Center and Medical School at Houston
Houston, Texas, United States
Institut Jules Bordet,Service De Microbiologie
Brussels, , Belgium
Hopital Erasme
Brussels, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Brussels, , Belgium
CHU de Charleroi - Hopital Civil Marie Curie
Lodelinsart, , Belgium
Mont-Godinne University Hospital
Yvoir, , Belgium
University Hospital Mont-Godinne
Yvoir, , Belgium
Klinik I fur Innere Medizin- Uniklinik Koln
Cologne, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik Haematologie/Onkologie
Mainz, , Germany
Infectious Diseases Unit, Rambam Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Infectious Diseases Unit
Tel Aviv, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Infectious Diseases Unit,Sheba Medical Center
Tel Litwinsky, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital VLL D Hebron
Barcelona, , Spain
Countries
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References
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Pappas PG, Vazquez JA, Oren I, Rahav G, Aoun M, Bulpa P, Ben-Ami R, Ferrer R, Mccarty T, Thompson GR, Schlamm H, Bien PA, Barbat SH, Wedel P, Oborska I, Tawadrous M, Hodges MR. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. J Antimicrob Chemother. 2023 Oct 3;78(10):2471-2480. doi: 10.1093/jac/dkad256.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C4791009
Identifier Type: OTHER
Identifier Source: secondary_id
APX001-201
Identifier Type: -
Identifier Source: org_study_id
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