Phase
Condition
Gynecological Infections
Sexually Transmitted Diseases (Stds)
Fungal Infections
Treatment
Ibrexafungerp
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Must have a documented eligible invasive and/or severe fungal disease that isrefractory or intolerant to Standard-of-Care treatment
Be able to tolerate medication orally or through a nasogastric (NG) tube orpercutaneous endoscopic gastrostomy (PEG) tube
Be able to understand and sign a written informed consent form (ICF), which must beobtained prior to treatment and any study-related procedures.
Be able to understand and sign a consent or authorization form which shall permitthe use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form).
Be able to understand and follow all study-related procedures including study drugadministration.
Agree to use a medically acceptable method of contraception while receivingprotocol-assigned product.
Exclusion
Key Exclusion Criteria:
An invasive fungal disease with CNS involvement.
Subject has an inappropriately controlled fungal disease source (e.g., persistentcatheters that cannot be removed and are likely the source of infection).
Subject is hemodynamically unstable, requiring vasopressor medication for bloodpressure support.
A life expectancy < 30 days.
Subject with abnormal liver test parameters: aspartate aminotransferase (AST),alanine aminotransferase (ALT) >10 x the upper limit of normal (ULN), and/or totalbilirubin > 5 x ULN.
Subject is pregnant or lactating.
Subject has used an investigational drug within 30 days prior to the baseline visit.
Study Design
Study Description
Connect with a study center
Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine
Graz, 8036
AustriaSite Not Available
Medical University Innsbruck
Innsbruck, 6020
AustriaSite Not Available
Universitätsklinikum Köln, Klinik I für Innere Medizin
Cologne, 50937
GermanySite Not Available
Universitätsklinikum Essen, Klinik für Infektiologie
Essen, 45147
GermanySite Not Available
Universitätsklinikum Frankfurt, Department of Internal Medicine II
Frankfurt, 60590
GermanySite Not Available
Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology
Leipzig, 04129
GermanySite Not Available
LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III
Munich, 81377
GermanySite Not Available
Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8
Nijmegen, Gelderland 6525
NetherlandsSite Not Available
Aga Khan University
Karachi, 74800
PakistanSite Not Available
Johese Clinical Research
Lyttelton, Centurion 0154
South AfricaSite Not Available
Into Research
Groenkloof, Pretoria 0181
South AfricaSite Not Available
Emmed Research
Muckleneuck, Pretoria 0002
South AfricaSite Not Available
Emmed Research
Muckleneuk, Pretoria 0002
South AfricaSite Not Available
FCRN Clinical Trial Centre
Three Rivers, Vereeniging 1935
South AfricaSite Not Available
Emmed Research
Pretoria, 0002
South AfricaSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, 28007
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainSite Not Available
St. George's University of London
London, SW17 0RE
United KingdomSite Not Available
The University of Manchester
Manchester, M13 9PL
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294-0006
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94143
United StatesSite Not Available
Emory University Hospital Midtown
Atlanta, Georgia 30322
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
Louisiana State University Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Wayne State University
Detroit, Michigan 48201
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
Stony Brook University Medical Center
Stony Brook, New York 11794
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania 15203
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37325
United StatesSite Not Available
University of Texas Southwestern Medical Center Dallas
Dallas, Texas 75390-8589
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesSite Not Available
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53705
United StatesSite Not Available

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