A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

PHASE3RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

December 11, 2024

Primary Completion Date

January 30, 2028

Study Completion Date

January 30, 2028

Conditions
CandidemiaCandidiasis, Invasive
Interventions
DRUG

Fosmanogepix

IV infusion

DRUG

Fosmanogepix

Oral tablet

DRUG

Caspofungin

IV infusion

DRUG

Fluconazole

Fluconazole oral capsule

DRUG

Placebo

Matching placebo for caspofungin (IV infusion)

DRUG

Placebo

Matching placebo for fluconazole (oral capsule)

DRUG

Placebo

Matching placebo for fosmanogepix (IV infusion)

DRUG

Placebo

Matching placebo for fosmanogepix (oral tablet)

Trial Locations (103)

220

RECRUITING

Far Eastern Memorial Hospital, New Taipei City

333

RECRUITING

Linkou Chang Gung Memorial Hospital, Taoyuan

1090

RECRUITING

Medical University Vienna, Vienna

RECRUITING

University Hospital Brussels, Brussels

1100

RECRUITING

University Hospital Graz, Department of Internal Medicine, Graz

RECRUITING

Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine, Vienna

1200

RECRUITING

Saint Luc University Hospital, Department of Internal Medicine, Brussels

1606

RECRUITING

"University Medical Center N. I. Pirogov, Burns and Plastic Surgery Clinic", Sofia

RECRUITING

"University Medical Center N. I. Pirogov, Clinic of Purulent-Septic Surgery", Sofia

2092

RECRUITING

Helen Joseph Hospital, Johannesburg

2145

RECRUITING

Westmead Hospital, Sydney

2193

RECRUITING

Milpark Hospital, Johannesburg

3000

RECRUITING

Peter MacCallum Cancer Center, State, Melbourne

RECRUITING

University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases, Leuven

3004

RECRUITING

The Alfred Hospital, Melbourne

3050

RECRUITING

Royal Melbourne Hospital, Parkville

3168

RECRUITING

Monash Medical Center Clayton, Clayton

3500

RECRUITING

Jessa Hospital, Hasselt

4004

RECRUITING

Eurohospital University Hospital, Plovdiv

4021

RECRUITING

Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases, Linz

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

4320

RECRUITING

Practice of R Moodley and MI Sarvan - Umhlanga, Umhlanga

5530

RECRUITING

UCL Mont-Godinne University Hospitals, Yvoir

8000

RECRUITING

General Hospital Saint-Jan, Bruges

10300

RECRUITING

Vajira Hospital, Bangkok

10700

RECRUITING

Siriraj Hospital, Bangkok

11000

RECRUITING

Taipei Medical University Hospital, Taipei

11527

RECRUITING

"Sotiria Chest Diseases Hospital of Athens", Athens

12100

RECRUITING

"Hospital S. Croce e Carle", Cuneo

13015

RECRUITING

Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections, Marseille

16132

RECRUITING

IRCCS Policlinic Hospital San Martino, Genoa

16499

RECRUITING

Ajou University Hospital, Suwon

20122

RECRUITING

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda, Milan

20132

RECRUITING

Hospital San Raffaele, IRCCS, Milan

20162

RECRUITING

Big Metropolitan Hospital Niguarda Regional Health Authority, Milan

27100

RECRUITING

Polyclinic San Matteo, IRCCS, Pavia

27514

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

28034

RECRUITING

University Hospital Ramon y Cajal, Department of Infectious Diseases, Madrid

30322

RECRUITING

Emory University Hospital - Clifton Road, Atlanta

34125

RECRUITING

Giuliano Isontina University Health Authority, Trieste

35000

RECRUITING

Rennes University Hospital Center - Hospital Pontchaillou, Rennes

35392

RECRUITING

University Hospital Giessen and Marburg GmbH, Giessen

37000

RECRUITING

Tours Regional University Hospital Center, Tours

40002

RECRUITING

Srinagarind Hospital, Khon Kaen

40506

RECRUITING

University of Kentucky College of Medicine, Lexington

41009

RECRUITING

University Hospital Virgen Macarena, Seville

41014

RECRUITING

University Hospital Nuestra Senora de Valme, Seville

41124

RECRUITING

University Polyclinic Hospital of Modena, Modena

41944

RECRUITING

Kyungpook National University Hospital, Daegu

44000

RECRUITING

Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases, Nantes

46202

RECRUITING

Indiana University Methodist Hospital, Indianapolis

48202

RECRUITING

Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases, Detroit

48903

RECRUITING

University Hospital Cruces, Barakaldo

50200

RECRUITING

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

50937

RECRUITING

University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases, Cologne

52621

RECRUITING

Chaim Sheba Medical Center, Department of Infectious Diseases, Ramat Gan

53100

RECRUITING

AOU Senese, Siena

54642

RECRUITING

"General Hospital of Thessaloniki Ippokratio", Thessaloniki

55455

RECRUITING

University of Minnesota, Minneapolis

56124

RECRUITING

University Hospital of Pisa, Pisa

58100

RECRUITING

Edith Wolfson Medical Center, Department of Infectious Diseases, Holon

60590

RECRUITING

Frankfurt University Clinic, Frankfurt am Main

63110

RECRUITING

Washington University School of Medicine, Infectious Diseases Clinical Research Unit, St Louis

69120

RECRUITING

University Hospital Heidelberg, Clinic for Anesthesiology, Heidelberg

77030

RECRUITING

Houston Methodist Hospital - Texas Medical Center, Houston

RECRUITING

The University of Texas Health Science Center at Houston, Houston

80054

RECRUITING

Amiens Picardie University Hospital - South, Intensive Care Unit (ICU), Amiens

89081

RECRUITING

University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU), Ulm

90110

RECRUITING

Songklanagarind Hospital, Hat Yai

93053

RECRUITING

University Hospital Regensburg, Regensburg

95107

RECRUITING

Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit, Argenteuil

95817

RECRUITING

UC Davis Medical Center, Sacramento

112201

RECRUITING

Taipei Veterans General Hospital, Taipei

119074

RECRUITING

National University Hospital, Singapore

169608

RECRUITING

Singapore General Hospital, Singapore

404327

RECRUITING

China Medical University Hospital, Taichung

407219

RECRUITING

Taichung Veterans General Hospital, Taichung

807377

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

833401

RECRUITING

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

3109601

RECRUITING

Rambam Health Care Campus, Institute of Infectious Diseases, Haifa

6423906

RECRUITING

The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit, Tel Aviv

7033001

RECRUITING

Shamir Medical Center, Department of Infectious Diseases, Ẕerifin

35294-0006

RECRUITING

University of Alabama at Birmingham School of Medicine, Department of Medicine, Birmingham

48109-5000

RECRUITING

University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center, Ann Arbor

B1641

RECRUITING

Central Hospital de San Isidro Melchor Posse, Buenos Aires

C1199ABB

RECRUITING

Buenos Aires Italian Hospital, Department of Infectious Diseases, Buenos Aires

X5016KEH

RECRUITING

Cordoba Private University Hospital, Department of Infectious Diseases, Córdoba

S2000CVB

RECRUITING

British Sanatorium SA, Rosario

B-1070

RECRUITING

Erasme Hospital, Department of Infectious and Tropical Diseases, Brussels

80810-040

RECRUITING

Hospital Our Lady of Grace, Curitiba

90035-903

RECRUITING

Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine, Porto Alegre

90610-000

RECRUITING

Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital, Porto Alegre

08270-070

RECRUITING

Santa Marcelina Hospital, São Paulo

115 27

RECRUITING

"LAIKO General Hospital", Athens

PC 10676

RECRUITING

"General Hospital of Athens Evangelismos, 5th Department of Internal Medicine and Infectious Diseases Unit", Athens

185 36

RECRUITING

Tzaneio General Hospital, Piraeus

0084

RECRUITING

Ryexo Clinical Research, Pretoria

RECRUITING

University of Pretoria / Steve Biko Academic Hospital, Pretoria

03722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08003

RECRUITING

Hospital del Mar, Department of Infectious Diseases, Barcelona

08035

RECRUITING

University Hospital Vall d'Hebron, Intensive Care Unit (ICU), Barcelona

08036

RECRUITING

Hospital Clinic of Barcelona, Department of Infectious Diseases, Barcelona

Sponsors
All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

lead

Basilea Pharmaceutica

INDUSTRY