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A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole (MARIO)

Primary Purpose

Candidiasis, Invasive, Candidemia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SCY-078
Fluconazole
Echinocandin
Sponsored by
Scynexis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Invasive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
  • Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).

Key Exclusion Criteria:

  • Subject has any of the following forms of invasive candidiasis at Screening:

    • Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
    • Osteomyelitis,
    • Endocarditis or myocarditis,
    • Meningitis, endophthalmitis, or any central nervous system infection,
    • Chronic disseminated candidiasis,
    • Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
    • Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
    • Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
    • Patients who failed a previous antifungal therapy for the same infection,
    • Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
  • Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
  • Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).

  • Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.

    o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.

  • Baseline QTcF ≥ 500 msec.

Sites / Locations

  • University of Alabama at Birmingham School of MedicineRecruiting
  • Banner University Medical Center-TucsonRecruiting
  • UC Davis Medical CenterRecruiting
  • Augusta University Medical CenterRecruiting
  • University of ChicagoRecruiting
  • Ochsner Medical CenterRecruiting
  • LSU Health Sciences CenterRecruiting
  • University of Maryland Medical CenterRecruiting
  • Johns Hopkins HospitalRecruiting
  • University of Michigan HospitalRecruiting
  • Henry Ford HospitalRecruiting
  • University of Minnesota Medical CenterRecruiting
  • Mayo Clinic - RochesterRecruiting
  • Washington University School of MedicineRecruiting
  • Mercury Street Medical Group, PLLCRecruiting
  • Duke UniversityRecruiting
  • University of Pennsylvania School of MedicineRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Rhode Island HospitalRecruiting
  • The Miriam HospitalRecruiting
  • University of Texas Health Science Center at HoustonRecruiting
  • Saint Luc University HospitalRecruiting
  • University Hospital GhentRecruiting
  • University Hospitals Leuven, Campus GasthuisbergRecruiting
  • University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of SurgeryRecruiting
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic SurgeryRecruiting
  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"Recruiting
  • Princess Margaret HospitalRecruiting
  • University Health Network- Toronto General HospitalRecruiting
  • McGill University Health CentreRecruiting
  • Victor Dupouy Hospital Center ArgenteuilRecruiting
  • Nantes University Hospital CenterRecruiting
  • Paris University Hospitals Center- Cochin HospitalRecruiting
  • Saint-Louis HospitalRecruiting
  • University Hospital Center of PoitiersRecruiting
  • University Hospital FreiburgRecruiting
  • Univeristy Hospital JenaRecruiting
  • University Hospital CologneRecruiting
  • Frankfurt University ClinicRecruiting
  • Municipal Hospital Munich GMbH/Hospital NeuperlachRecruiting
  • Helios Clinic WuppertalRecruiting
  • General Hospital of Athens "Evangelismos", 1st Department of Critical CareRecruiting
  • General Hospital of Athens "Evangelismos"Recruiting
  • LAIKO General HospitalRecruiting
  • University General Hospital "Attikon"Recruiting
  • General Hospital of Thessaloniki "Ippokratio"Recruiting
  • Lady Davis Carmel Medical Center, Infectious Diseases UnitRecruiting
  • Rambam Health Care Campus, Institute of Infectious DiseasesRecruiting
  • Chaim Sheba Medical CenterRecruiting
  • IRCCS- University Hospital San Martino-ISTRecruiting
  • Big Metropolitan Hospital Niguarda Regional Health AuthorityRecruiting
  • University Polyclinic Hospital of ModenaRecruiting
  • Central Friuli University Healthcare CompanyRecruiting
  • Keimyung University - Dongsan Medical CenterRecruiting
  • CHA Bundang Medical Center, CHA UniversityRecruiting
  • Gangnam Severance HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Wonju Severance Christian HospitalRecruiting
  • Lakeview HospitalRecruiting
  • Netcare Jakaranda HospitalRecruiting
  • Zuid-Afrikaans HospitalRecruiting
  • Life Groenkloof HospitalRecruiting
  • FCRN Clinical Trials CentreRecruiting
  • Mediclinic VictoriaRecruiting
  • University of Pretoria and Steve Biko Academic HospitalRecruiting
  • University Hospital Virgen MacarenaRecruiting
  • Hospital del Mar Medical Research Institute (IMIM)Recruiting
  • General University Hospital Gregorio Maranon
  • University Hospital de La PrincesaRecruiting
  • University Hospital Puerta de Hierro MajadahondaRecruiting
  • University and Polytechnic Hospital La FeRecruiting
  • University Clinical Hospital of ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV echinocandin followed by oral ibrexafungerp (SCY-078)

IV echinocandin followed by oral fluconazole

Arm Description

Outcomes

Primary Outcome Measures

All-cause mortality (US FDA Only)
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee

Secondary Outcome Measures

Global Response at Day 14
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee

Full Information

First Posted
December 16, 2021
Last Updated
August 22, 2023
Sponsor
Scynexis, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05178862
Brief Title
A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
Acronym
MARIO
Official Title
A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Invasive, Candidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV echinocandin followed by oral ibrexafungerp (SCY-078)
Arm Type
Experimental
Arm Title
IV echinocandin followed by oral fluconazole
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SCY-078
Other Intervention Name(s)
Ibrexafungerp
Intervention Description
Oral ibrexafungerp (SCY-078) as step-down therapy.
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Diflucan
Intervention Description
Oral fluconazole (SCY-078) as step-down therapy.
Intervention Type
Drug
Intervention Name(s)
Echinocandin
Other Intervention Name(s)
Caspofungin, Micafungin, Anidulafungin
Intervention Description
Intravenous echinocandin
Primary Outcome Measure Information:
Title
All-cause mortality (US FDA Only)
Description
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Time Frame
Day 30
Title
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
Description
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Global Response at Day 14
Description
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed. Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation). Key Exclusion Criteria: Subject has any of the following forms of invasive candidiasis at Screening: Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed), Osteomyelitis, Endocarditis or myocarditis, Meningitis, endophthalmitis, or any central nervous system infection, Chronic disseminated candidiasis, Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract, Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens, Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection, Patients who failed a previous antifungal therapy for the same infection, Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis. Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN). Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9). Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin. o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible. Baseline QTcF ≥ 500 msec.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Angulo, MD
Phone
+1 201-884-5471
Email
david.angulo@scynexis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Anastasi
Phone
1-917-733-1108
Email
christopher.anastasi@scynexis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Angulo, MD
Organizational Affiliation
Scynexis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shayna Bryan
First Name & Middle Initial & Last Name & Degree
Tood McCarty, MD
Facility Name
Banner University Medical Center-Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Elizondo
First Name & Middle Initial & Last Name & Degree
Mohanad Al-Obaidi, MD
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Thompson, MD
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Vazquez, MD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Friedman, MD
First Name & Middle Initial & Last Name & Degree
Daniel Friedman, MD
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Comeaux
First Name & Middle Initial & Last Name & Degree
Jonathan Hand, MD
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobie Leonards
First Name & Middle Initial & Last Name & Degree
Paulette Pinargote Cornejo, MD
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Rogers
First Name & Middle Initial & Last Name & Degree
John Baddley, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilpa Gopinath
First Name & Middle Initial & Last Name & Degree
Nitipong Permpalung, MD
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Miceli, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Alangaden, MD
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Eichten
First Name & Middle Initial & Last Name & Degree
Jo-Anne Young, MD
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ella Nadarevic
First Name & Middle Initial & Last Name & Degree
Paschalis Vergidis, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Richmond
Email
cmrichmond@wustl.edu
First Name & Middle Initial & Last Name & Degree
Andrej Spec, MD
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Pullman, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Daly
First Name & Middle Initial & Last Name & Degree
Barbara Alexander, MD
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Blumberg, MD
First Name & Middle Initial & Last Name & Degree
Emily Blumberg, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minh-Hong Nguyen, MD
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Rogers
First Name & Middle Initial & Last Name & Degree
Ralph Rogers, MD
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Rogers
First Name & Middle Initial & Last Name & Degree
Ralph Rogers, MD
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehriban Mammadova
Phone
713-500-6761
Email
mehriban.mammadova@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Luis Ostrosky-Zeichner, MD
Facility Name
Saint Luc University Hospital
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine D'Aoust
First Name & Middle Initial & Last Name & Degree
Leila Belkhir, MD
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Else Caluwe
First Name & Middle Initial & Last Name & Degree
Marie Angelique De Scheerder, MD
Facility Name
University Hospitals Leuven, Campus Gasthuisberg
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolai Shannon
First Name & Middle Initial & Last Name & Degree
Eric Van Wijngaerden, MD
Facility Name
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikola Hadzhidemirov
First Name & Middle Initial & Last Name & Degree
Nikolay Belev, MD
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarita Stoyanova
First Name & Middle Initial & Last Name & Degree
Ivan Poromanski, MD
Facility Name
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
City
Stara Zagora
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Ivanova
First Name & Middle Initial & Last Name & Degree
Georgi Arabadzhiev, MD
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melody Obaseki
First Name & Middle Initial & Last Name & Degree
Coleman Rotstein, MD
Facility Name
University Health Network- Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melody Obaseki
First Name & Middle Initial & Last Name & Degree
Coleman Rotstein, MD
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Maguigad
First Name & Middle Initial & Last Name & Degree
Ewa Rajda, MD
Facility Name
Victor Dupouy Hospital Center Argenteuil
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetan Plantefeve
First Name & Middle Initial & Last Name & Degree
Gaetan Plantefeve, MD
Facility Name
Nantes University Hospital Center
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremie Orain
First Name & Middle Initial & Last Name & Degree
David Boutoille, MD
Facility Name
Paris University Hospitals Center- Cochin Hospital
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Marin
First Name & Middle Initial & Last Name & Degree
Jean-Paul Mira
Facility Name
Saint-Louis Hospital
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miresta Previlon
First Name & Middle Initial & Last Name & Degree
Blandine Denis, MD
Facility Name
University Hospital Center of Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucile Decanter
First Name & Middle Initial & Last Name & Degree
Jean-Marie Turmel, MD
Facility Name
University Hospital Freiburg
City
Freiburg
State/Province
Baden-Wuerttemberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heike Spitznagel
First Name & Middle Initial & Last Name & Degree
Siegbert Rieg, MD
Facility Name
Univeristy Hospital Jena
City
Jena
State/Province
Thuringia
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffi Kolanos
First Name & Middle Initial & Last Name & Degree
Mathias Pletz, MD
Facility Name
University Hospital Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Koerfgen
First Name & Middle Initial & Last Name & Degree
Philipp Koehler, MD
Facility Name
Frankfurt University Clinic
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franziska Ebeling
First Name & Middle Initial & Last Name & Degree
Johanna Kessel, MD
Facility Name
Municipal Hospital Munich GMbH/Hospital Neuperlach
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heike Stephan
First Name & Middle Initial & Last Name & Degree
Meinolf Karthaus, MD
Facility Name
Helios Clinic Wuppertal
City
Wuppertal
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artur Wiatrak
First Name & Middle Initial & Last Name & Degree
Blasius Liss, MD
Facility Name
General Hospital of Athens "Evangelismos", 1st Department of Critical Care
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eirini Daikou
First Name & Middle Initial & Last Name & Degree
Anastasia Kotanidou, MD
Facility Name
General Hospital of Athens "Evangelismos"
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panayiotis Christodoulou
First Name & Middle Initial & Last Name & Degree
Vasileios Papastamopoulos,, MD
Facility Name
LAIKO General Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Apostolidi
First Name & Middle Initial & Last Name & Degree
Nikolaos Sipsas, MD
Facility Name
University General Hospital "Attikon"
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrysanthi Oikonomopoulou
First Name & Middle Initial & Last Name & Degree
Anastasia Antoniadou, MD
Facility Name
General Hospital of Thessaloniki "Ippokratio"
City
Thessaloníki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Kitsou
First Name & Middle Initial & Last Name & Degree
Emmanuel Roilides, MD
Facility Name
Lady Davis Carmel Medical Center, Infectious Diseases Unit
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shani Gitman
First Name & Middle Initial & Last Name & Degree
Gabriel Weber, MD
Facility Name
Rambam Health Care Campus, Institute of Infectious Diseases
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Fares Sabik
First Name & Middle Initial & Last Name & Degree
Anat Stern, MD
Facility Name
Chaim Sheba Medical Center
City
Tel HaShomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellada Khananyev
First Name & Middle Initial & Last Name & Degree
Dafna Yahav, MD
Facility Name
IRCCS- University Hospital San Martino-IST
City
Genoa
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulia Viglietti
First Name & Middle Initial & Last Name & Degree
Matteo Bassetti, MD
Facility Name
Big Metropolitan Hospital Niguarda Regional Health Authority
City
Milan
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico D'Amico
First Name & Middle Initial & Last Name & Degree
Marco Merli, MD
Facility Name
University Polyclinic Hospital of Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulia Nardini
First Name & Middle Initial & Last Name & Degree
Cristina Mussini, MD
Facility Name
Central Friuli University Healthcare Company
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duria Raffaele
First Name & Middle Initial & Last Name & Degree
Carlo Tascini, MD
Facility Name
Keimyung University - Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Sil Park
First Name & Middle Initial & Last Name & Degree
Miri Hyun, MD
Facility Name
CHA Bundang Medical Center, CHA University
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeeun Baek
First Name & Middle Initial & Last Name & Degree
Jong Hun Kim, MD
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeonghwa Jo
First Name & Middle Initial & Last Name & Degree
Sang Hoon Han, MD
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hye Lim
First Name & Middle Initial & Last Name & Degree
Jan Yung Choi, MD
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung Sook Han
First Name & Middle Initial & Last Name & Degree
Young Keun Kim, MD
Facility Name
Lakeview Hospital
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismail Haroon Mitha, MD
Facility Name
Netcare Jakaranda Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Breedt, MD
Email
jbreedt@gpnet.net
Facility Name
Zuid-Afrikaans Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larry Mey, MD
Email
drlarry@johese.co.za
Facility Name
Life Groenkloof Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Siebert, MD
Email
Richard.s@internists.co.za
Facility Name
FCRN Clinical Trials Centre
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1935
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Geldenhuys, MD
Facility Name
Mediclinic Victoria
City
Tongaat
State/Province
KwaZulu-Natal
ZIP/Postal Code
4400
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajendran Moodley, MD
Facility Name
University of Pretoria and Steve Biko Academic Hospital
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornelius Meinties
First Name & Middle Initial & Last Name & Degree
Fathima Paruk, MD
Facility Name
University Hospital Virgen Macarena
City
Seville
State/Province
Andalusia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belen Gallego Mesa
First Name & Middle Initial & Last Name & Degree
Luis Eduardo Lopez Cortes, MD
Facility Name
Hospital del Mar Medical Research Institute (IMIM)
City
Barcelona
State/Province
Catalonia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Fernandez Ferrer
First Name & Middle Initial & Last Name & Degree
Joan Gomez Junyent, MD
Facility Name
General University Hospital Gregorio Maranon
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Rodriguez Fernandez
First Name & Middle Initial & Last Name & Degree
Patricia Munoz Garcia, MD
Facility Name
University Hospital de La Princesa
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianela Ciudad Sanudo
First Name & Middle Initial & Last Name & Degree
Marianela Ciudad Sanudo, MD
Facility Name
University Hospital Puerta de Hierro Majadahonda
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Martinez Rodriguez
First Name & Middle Initial & Last Name & Degree
Ana Fernandez Cruz, MD
Facility Name
University and Polytechnic Hospital La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ainoa Del Carmen
First Name & Middle Initial & Last Name & Degree
David Martinez Cuadron, MD
Facility Name
University Clinical Hospital of Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Borrero
First Name & Middle Initial & Last Name & Degree
Carlos Solano Vercet, MD

12. IPD Sharing Statement

Learn more about this trial

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

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