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RECRUITING

NCT05421858

PHASE3

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

Sponsor: Basilea Pharmaceutica

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis. Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules. Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital. The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%. The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.

Official title: An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-12-11

Completion Date

2028-01-30

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Candidemia Candidiasis, 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)

Inclusion Criteria: 1. Patients ≥ 18 years (or the minimum country-specific age of consent if \> 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf. 2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization. 3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary. Exclusion Criteria: 1. Existing infection 1. Infection known to be due to Candida krusei, in blood or any other normally sterile site. 2. Inappropriate fungal infection source control. 3. Diagnosis of certain deep-seated Candida infections. 2. Life expectancy of \< 72 hours in the opinion of the investigator. 3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration. 4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary). 5. 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 opportunistic infection within 6 months prior to Screening. 6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study. 7. Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication. 8. Received \> 2 days (\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., \> 2 doses of a once daily antifungal agent or \> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B). 9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer). 10. Prior participation in this or any previous study of fosmanogepix. 11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome. 12. Female patient is pregnant or lactating. 13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients. 14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.

Locations (130)

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

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

UC Davis Medical Center

Sacramento, California, United States

Emory University Hospital - Clifton Road

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Indiana University Methodist Hospital

Indianapolis, Indiana, United States

University of Kentucky College of Medicine

Lexington, Kentucky, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

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

Ann Arbor, Michigan, United States

DMC Harper University Hospital

Detroit, Michigan, United States

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

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine, Infectious Diseases Clinical Research Unit

St Louis, Missouri, United States

Weill Cornell Medical College - NewYork-Presbyterian Hospital

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Houston Methodist Hospital - Texas Medical Center

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Carilion Clinic

Roanoke, Virginia, United States

Central Hospital de San Isidro Melchor Posse

Buenos Aires, Argentina

Buenos Aires Italian Hospital, Department of Infectious Diseases

Buenos Aires, Argentina

Cordoba Private University Hospital, Department of Infectious Diseases

Córdoba, Argentina

Italian Hospital of La Plata, Department of Infectious Diseases

La Plata, Argentina

Central Hospital Mendoza

Mendoza, Argentina

British Sanatorium SA

Rosario, Argentina

Westmead Hospital

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Center, State

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Monash Medical Center Clayton

Clayton, Australia

University Hospital Graz, Department of Internal Medicine

Graz, Austria

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

Linz, Austria

Medical University Vienna

Vienna, Austria

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

Vienna, Austria

General Hospital Saint-Jan

Bruges, Belgium

University Hospital Brussels

Brussels, Belgium

Saint Luc University Hospital, Department of Internal Medicine

Brussels, Belgium

Erasme Hospital, Department of Infectious and Tropical Diseases

Brussels, Belgium

Jessa Hospital

Hasselt, Belgium

University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases

Leuven, Belgium

UCL Mont-Godinne University Hospitals

Yvoir, Belgium

HC-UFPR

Curitiba, Paraná, Brazil

Hospital Our Lady of Grace

Curitiba, Paraná, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Santa Marcelina Hospital

São Paulo, Brazil

Eurohospital University Hospital

Plovdiv, Bulgaria

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

Sofia, Bulgaria

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

Sofia, Bulgaria

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Zhejiang Provincal Hospital of Chinese Medicine

Hangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Lishui People's Hospital

Lishui, China

Liuzhou People's Hospital

Liuchow, China

The 1st Affiliated Hospital of Nanchang University

Nanchang, China

Qingyuan People's Hospital

Qingyuan, China

Wuxi People's Hospital

Wuxi, China

Cardiomet CEQUIN Foundation, Department of Nephrology

Armenia, Colombia

Luz Castro de Gutierrez Medellin General Hospital, Research Center

Medellín, Colombia

Pablo Tobon Uribe Hospital

Medellín, Colombia

High Technology Medical Institute S.A.S, IMAT S.A.S.

Montería, Colombia

Somer Clinic

Rionegro, Colombia

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

Amiens, France

Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit

Argenteuil, France

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

Marseille, France

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

Nantes, France

Rennes University Hospital Center - Hospital Pontchaillou

Rennes, France

Tours Regional University Hospital Center

Tours, France

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

Ulm, Baden-Wurttemberg, Germany

University Hospital Regensburg

Regensburg, Bavaria, Germany

Frankfurt University Clinic

Frankfurt am Main, Hesse, Germany

University Hospital Giessen and Marburg GmbH

Giessen, Hesse, Germany

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

Cologne, North Rhine-Westphalia, Germany

University Hospital Heidelberg, Clinic for Anesthesiology

Heidelberg, Germany

"LAIKO" General Hospital

Athens, Greece

"Sotiria" Chest Diseases Hospital of Athens

Athens, Greece

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

Athens, Greece

Tzaneio General Hospital

Piraeus, Greece

General Hospital of Thessaloniki "Ippokratio"

Thessaloniki, Greece

Rambam Health Care Campus, Institute of Infectious Diseases

Haifa, Israel

Edith Wolfson Medical Center, Department of Infectious Diseases

Holon, Israel

Chaim Sheba Medical Center, Department of Infectious Diseases

Ramat Gan, Israel

The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit

Tel Aviv, Israel

Shamir Medical Center, Department of Infectious Diseases

Ẕerifin, Israel

Hospital "S. Croce e Carle"

Cuneo, Italy

IRCCS Policlinic Hospital San Martino

Genoa, Italy

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

Milan, Italy

Hospital San Raffaele, IRCCS

Milan, Italy

Big Metropolitan Hospital Niguarda Regional Health Authority

Milan, Italy

University Polyclinic Hospital of Modena

Modena, Italy

Polyclinic San Matteo, IRCCS

Pavia, Italy

University Hospital of Pisa

Pisa, Italy

AOU Senese

Siena, Italy

Giuliano Isontina University Health Authority

Trieste, Italy

National University Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Helen Joseph Hospital

Johannesburg, South Africa

Milpark Hospital

Johannesburg, South Africa

Ryexo Clinical Research

Pretoria, South Africa

University of Pretoria / Steve Biko Academic Hospital

Pretoria, South Africa

Practice of R Moodley and MI Sarvan - Umhlanga

Umhlanga, South Africa

Kyungpook National University Hospital

Daegu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

University Hospital Virgen Macarena

Seville, Andalusia, Spain

University Hospital Nuestra Senora de Valme

Seville, Andalusia, Spain

Hospital del Mar, Department of Infectious Diseases

Barcelona, Catalonia, Spain

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

Barcelona, Catalonia, Spain

Hospital Clinic of Barcelona, Department of Infectious Diseases

Barcelona, Catalonia, Spain

University Hospital Ramon y Cajal, Department of Infectious Diseases

Madrid, Madrid, Spain

University Hospital Cruces

Barakaldo, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Vajira Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Songklanagarind Hospital

Hat Yai, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (130)