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

Status: Recruiting
Location: See all (103) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.

Locations
United States
Alabama
University of Alabama at Birmingham School of Medicine, Department of Medicine
RECRUITING
Birmingham
California
UC Davis Medical Center
RECRUITING
Sacramento
Georgia
Emory University Hospital - Clifton Road
RECRUITING
Atlanta
Indiana
Indiana University Methodist Hospital
RECRUITING
Indianapolis
Kentucky
University of Kentucky College of Medicine
RECRUITING
Lexington
Michigan
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
RECRUITING
Ann Arbor
Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases
RECRUITING
Detroit
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Texas
Houston Methodist Hospital - Texas Medical Center
RECRUITING
Houston
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Other Locations
Argentina
Buenos Aires Italian Hospital, Department of Infectious Diseases
RECRUITING
Buenos Aires
Central Hospital de San Isidro Melchor Posse
RECRUITING
Buenos Aires
Cordoba Private University Hospital, Department of Infectious Diseases
RECRUITING
Córdoba
British Sanatorium SA
RECRUITING
Rosario
Australia
Monash Medical Center Clayton
RECRUITING
Clayton
Peter MacCallum Cancer Center, State
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Parkville
Westmead Hospital
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
University Hospital Graz, Department of Internal Medicine
RECRUITING
Graz
Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases
RECRUITING
Linz
Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine
RECRUITING
Vienna
Medical University Vienna
RECRUITING
Vienna
Belgium
General Hospital Saint-Jan
RECRUITING
Bruges
Erasme Hospital, Department of Infectious and Tropical Diseases
RECRUITING
Brussels
Saint Luc University Hospital, Department of Internal Medicine
RECRUITING
Brussels
University Hospital Brussels
RECRUITING
Brussels
Jessa Hospital
RECRUITING
Hasselt
University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases
RECRUITING
Leuven
UCL Mont-Godinne University Hospitals
RECRUITING
Yvoir
Brazil
Hospital Our Lady of Grace
RECRUITING
Curitiba
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
RECRUITING
Porto Alegre
Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine
RECRUITING
Porto Alegre
Santa Marcelina Hospital
RECRUITING
São Paulo
Bulgaria
Eurohospital University Hospital
RECRUITING
Plovdiv
University Medical Center N. I. Pirogov, Burns and Plastic Surgery Clinic
RECRUITING
Sofia
University Medical Center N. I. Pirogov, Clinic of Purulent-Septic Surgery
RECRUITING
Sofia
France
Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)
RECRUITING
Amiens
Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit
RECRUITING
Argenteuil
Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections
RECRUITING
Marseille
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
RECRUITING
Nantes
Rennes University Hospital Center - Hospital Pontchaillou
RECRUITING
Rennes
Tours Regional University Hospital Center
RECRUITING
Tours
Germany
University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases
RECRUITING
Cologne
Frankfurt University Clinic
RECRUITING
Frankfurt Am Main
University Hospital Giessen and Marburg GmbH
RECRUITING
Giessen
University Hospital Heidelberg, Clinic for Anesthesiology
RECRUITING
Heidelberg
University Hospital Regensburg
RECRUITING
Regensburg
University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)
RECRUITING
Ulm
Greece
General Hospital of Athens Evangelismos, 5th Department of Internal Medicine and Infectious Diseases Unit
RECRUITING
Athens
LAIKO General Hospital
RECRUITING
Athens
Sotiria Chest Diseases Hospital of Athens
RECRUITING
Athens
Tzaneio General Hospital
RECRUITING
Piraeus
General Hospital of Thessaloniki Ippokratio
RECRUITING
Thessaloniki
Israel
Rambam Health Care Campus, Institute of Infectious Diseases
RECRUITING
Haifa
Edith Wolfson Medical Center, Department of Infectious Diseases
RECRUITING
Holon
Chaim Sheba Medical Center, Department of Infectious Diseases
RECRUITING
Ramat Gan
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
RECRUITING
Tel Aviv
Shamir Medical Center, Department of Infectious Diseases
RECRUITING
Ẕerifin
Italy
Hospital S. Croce e Carle
RECRUITING
Cuneo
IRCCS Policlinic Hospital San Martino
RECRUITING
Genoa
Big Metropolitan Hospital Niguarda Regional Health Authority
RECRUITING
Milan
Hospital San Raffaele, IRCCS
RECRUITING
Milan
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
RECRUITING
Milan
University Polyclinic Hospital of Modena
RECRUITING
Modena
Polyclinic San Matteo, IRCCS
RECRUITING
Pavia
University Hospital of Pisa
RECRUITING
Pisa
AOU Senese
RECRUITING
Siena
Giuliano Isontina University Health Authority
RECRUITING
Trieste
Republic of Korea
Kyungpook National University Hospital
RECRUITING
Daegu
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Singapore
National University Hospital
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
South Africa
Helen Joseph Hospital
RECRUITING
Johannesburg
Milpark Hospital
RECRUITING
Johannesburg
Ryexo Clinical Research
RECRUITING
Pretoria
University of Pretoria / Steve Biko Academic Hospital
RECRUITING
Pretoria
Practice of R Moodley and MI Sarvan - Umhlanga
RECRUITING
Umhlanga
Spain
University Hospital Cruces
RECRUITING
Barakaldo
Hospital Clinic of Barcelona, Department of Infectious Diseases
RECRUITING
Barcelona
Hospital del Mar, Department of Infectious Diseases
RECRUITING
Barcelona
University Hospital Vall d'Hebron, Intensive Care Unit (ICU)
RECRUITING
Barcelona
University Hospital Ramon y Cajal, Department of Infectious Diseases
RECRUITING
Madrid
University Hospital Nuestra Senora de Valme
RECRUITING
Seville
University Hospital Virgen Macarena
RECRUITING
Seville
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Thailand
Siriraj Hospital
RECRUITING
Bangkok
Vajira Hospital
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital
RECRUITING
Chiang Mai
Songklanagarind Hospital
RECRUITING
Hat Yai
Srinagarind Hospital
RECRUITING
Khon Kaen
Contact Information
Primary
Manuel Häckl, MD
manuel.haeckl@basilea.com
+41 76 302 53 10
Backup
Marc Engelhardt, MD
marc.engelhardt@basilea.com
+41 79 701 0551
Time Frame
Start Date: 2024-12-11
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 450
Treatments
Experimental: Fosmanogepix IV/oral
Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to the oral form of fosmanogepix which is taken by mouth.~Matching placebos for caspofungin and fluconazole will also be administered (a placebo does not have any medicine in it but looks just like the caspofungin and fluconazole).
Active_comparator: Caspofungin IV/ Fluconazole oral
Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to oral fluconazole which is taken by mouth.~Matching placebos for fosmanogepix will also be administered (a placebo does not have any medicine in it but looks just like the medicine fosmanogepix being studied).
Related Therapeutic Areas
Sponsors
Leads: Basilea Pharmaceutica
Collaborators: Biomedical Advanced Research and Development Authority

This content was sourced from clinicaltrials.gov

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