Phase
Condition
Systemic Candidiasis
Vaginal Infection
Systemic Fungal Infections
Treatment
Caspofungin
PF-07842805
Fluconazole
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients ≥ 18 years (or the minimum country-specific age of consent if > 18) atScreening who have provided signed informed consent indicating that they understandthe purpose of, and procedures required for, the study, and are willing toparticipate in the study. If the patient is unable to consent for himself/herself, alegally authorized representative must provide informed consent on his/her behalf.
Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-bloodspecimen obtained within ≤ 96 hours (4 days) before randomization, and on clinicalcriteria judged attributable to candidemia/invasive candidiasis occurring at anytime from ≤ 12 hours prior to the qualifying positive index culture being takenthrough to randomization.
Patient's condition allows for appropriate infection source control measures,including removal of pre-existing intravascular catheters and devices, if necessary.
Exclusion
Exclusion Criteria:
Existing infection
Infection known to be due to Candida krusei, in blood or any other normallysterile site.
Inappropriate fungal infection source control.
Diagnosis of certain deep-seated Candida infections.
Life expectancy of < 72 hours in the opinion of the investigator.
Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, orhemofiltration.
Ongoing neurological disorders, including specified conditions presenting with aCTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence ofthe current episode of candidemia / invasive candidiasis are not exclusionary).
Patients with known human immunodeficiency virus infection, who have CD4+ count < 200/mm3 or viral load > 400 copies/mL), or who have had an active opportunisticinfection within 6 months prior to Screening.
Other medical or psychiatric condition or laboratory abnormality that may increasethe risk of study participation or make the patient inappropriate for the study.
Current use of any prohibited concomitant medications or those unwilling/unable touse a permitted concomitant medication.
Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment atapproved doses and frequency to treat the current episode of candidemia and/orinvasive candidiasis (e.g., > 2 doses of a once daily antifungal agent or > 4 dosesof a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia orinvasive candidiasis while on prophylaxis with an azole or amphotericin B).
Previous administration with an investigational drug or investigational vaccinewithin 30 days or 5 half-lives preceding the first dose of study drug used in thisstudy (whichever is longer).
Prior participation in this or any previous study of fosmanogepix.
Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT orAST ≥ 5 × ULN or total bilirubin > 3 × ULN unless this is due to isolatedhyperbilirubinemia or documented Gilbert's syndrome.
Female patient is pregnant or lactating.
Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin,fluconazole or to any of their excipients.
Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and Sponsor andSponsor delegate employees directly involved in the conduct of the study and theirfamily members.
Study Design
Connect with a study center
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Monash Medical Center Clayton
Clayton, 3168
AustraliaActive - Recruiting
Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases
Linz, 4021
AustriaActive - Recruiting
Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine
Vienna, 1100
AustriaActive - Recruiting
Medical University Vienna
Vienna, 1090
AustriaActive - Recruiting
General Hospital Saint-Jan
Brugge, 8000
BelgiumActive - Recruiting
Erasme Hospital, Department of Infectious and Tropical Diseases
Brussels, B-1070
BelgiumActive - Recruiting
Saint Luc University Hospital, Department of Internal Medicine
Brussels, 1200
BelgiumActive - Recruiting
University Hospital Brussels
Brussels, 1090
BelgiumActive - Recruiting
Jessa Hospital
Hasselt, 3500
BelgiumActive - Recruiting
University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases
Leuven, 3000
BelgiumActive - Recruiting
UCL Mont-Godinne University Hospitals
Yvoir, 5530
BelgiumActive - Recruiting
Eurohospital University Hospital
Plovdiv, 4004
BulgariaActive - Recruiting
University Medical Center "N. I. Pirogov"
Sofia, 1606
BulgariaSite Not Available
University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic
Sofia, 1606
BulgariaActive - Recruiting
University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery
Sofia, 1606
BulgariaActive - Recruiting
Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)
Amiens, 80054
FranceActive - Recruiting
Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit
Argenteuil, 95107
FranceActive - Recruiting
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
Nantes, 44000
FranceActive - Recruiting
Tours Regional University Hospital Center
Tours, 37000
FranceActive - Recruiting
University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)
Ulm, Baden-Wuerttemberg 89081
GermanyActive - Recruiting
University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases
Cologne, North Rhine-Westphalia 50937
GermanyActive - Recruiting
University Hospital Heidelberg, Clinic for Anesthesiology
Heidelberg, 69120
GermanyActive - Recruiting
"LAIKO" General Hospital
Athens, 115 27
GreeceActive - Recruiting
"Sotiria" Chest Diseases Hospital of Athens
Athens, 11527
GreeceActive - Recruiting
General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit
Athens, PC 10676
GreeceActive - Recruiting
Tzaneio General Hospital
Piraeus, 185 36
GreeceActive - Recruiting
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, 54642
GreeceActive - Recruiting
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa, 3109601
IsraelActive - Recruiting
Edith Wolfson Medical Center, Department of Infectious Diseases
Holon, 58100
IsraelActive - Recruiting
Chaim Sheba Medical Center, Department of Infectious Diseases
Ramat Gan, 52621
IsraelActive - Recruiting
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
Tel Aviv, 6423906
IsraelActive - Recruiting
Shamir Medical Center, Department of Infectious Diseases
Zerifin, 7033001
IsraelActive - Recruiting
Hospital "S. Croce e Carle"
Cuneo, 12100
ItalyActive - Recruiting
IRCCS Policlinic Hospital San Martino
Genoa, 16132
ItalyActive - Recruiting
Hospital San Raffaele, IRCCS
Milan, 20132
ItalyActive - Recruiting
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122
ItalyActive - Recruiting
Polyclinic San Matteo, IRCCS
Pavia, 27100
ItalyActive - Recruiting
University Hospital of Pisa
Pisa, 56124
ItalyActive - Recruiting
Giuliano Isontina University Health Authority
Trieste, 34125
ItalyActive - Recruiting
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon, 16499
Korea, Republic ofActive - Recruiting
Ryexo Clinical Research
Pretoria, 0084
South AfricaActive - Recruiting
University of Pretoria / Steve Biko Academic Hospital
Pretoria, 0084
South AfricaActive - Recruiting
Practice of R Moodley and MI Sarvan - Umhlanga
Umhlanga, 4320
South AfricaActive - Recruiting
University Hospital Nuestra Senora de Valme
Seville, Andalusia 41014
SpainActive - Recruiting
University Hospital Virgen Macarena
Seville, Andalusia 41009
SpainActive - Recruiting
Hospital Clinic of Barcelona, Department of Infectious Diseases
Barcelona, Catalonia 08036
SpainActive - Recruiting
Hospital del Mar, Department of Infectious Diseases
Barcelona, Catalonia 08003
SpainActive - Recruiting
University Hospital Ramon y Cajal, Department of Infectious Diseases
Madrid, Community Of Madrid 28034
SpainActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807377
TaiwanActive - Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 404327
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 407219
TaiwanActive - Recruiting
Taipei Medical University Hospital
Taipei, 11000
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112201
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333
TaiwanActive - Recruiting
Siriraj Hospital
Bangkok, 10700
ThailandActive - Recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
ThailandActive - Recruiting
Songklanagarind Hospital
Hat Yai, 90110
ThailandActive - Recruiting
UC Davis Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
Emory University Hospital - Clifton Road
Atlanta, Georgia 30322
United StatesActive - Recruiting
Indiana University Methodist Hospital
Indianapolis, Indiana 46202
United StatesActive - Recruiting
University of Kentucky College of Medicine
Lexington, Kentucky 40506
United StatesActive - Recruiting
Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases
Detroit, Michigan 48202
United StatesActive - Recruiting
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
Saint Louis, Missouri 63110
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
Houston Methodist Hospital - Texas Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting
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