Last updated 11 days ago
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
450 patients around the world
Available in Brazil, United States, Argentina, Colombia
Basilea Pharmaceutica
15Research sites
450Patients around the world
This study is for people with
Invasive Candidiasis
Candidemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- Existing infection.Infection known to be due to Candida krusei, in blood or any other normally sterile 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, or hemofiltration.Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2.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.Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.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 within the 96 hours prior to randomization.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.Prior participation in this or any previous study of fosmanogepix.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.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 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.
Sites
Hospital Central - Capital
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Hospital Italiano de La Plata
Recruiting
Hospital Central de San Isidro "Dr. Melchor Ángel Posse"
Recruiting
Hospital Privado de Córdoba
Recruiting
Sanatorio Británico - Rosario
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Hospital Nossa Senhora das Graças
Recruiting
Hospital de Clínicas de Porto Alegre (HCPA)
Recruiting
Hospital Santa Marcelina
Recruiting
SponsorBasilea Pharmaceutica
Study typeInterventional
Conditions
CandidemiaInvasive Candidiasis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05421858
