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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05421858
Other study ID # FMGX-CS-301
Secondary ID 2022-500455-23-0
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 15, 2024
Est. completion date July 15, 2027

Study information

Verified date April 2024
Source Basilea Pharmaceutica
Contact Manuel Häckl, MD
Phone +41 76 302 53 10
Email manuel.haeckl@basilea.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. Fosmaogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmaogepix 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. We will compare the experience of patients receiving fosmanogepix to those receiving caspofungin/ fluconazole. This will help us determine if fosmanogepix is safe and effective. Patients will continue treatment for a maximum of 6 weeks depending on whether the infection has cleared and whether the symptoms related to the infection has improved. During this time, they will have study visits for up to 10 times. There will also be a follow-up visit 6 weeks after the study treatment was stopped.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date July 15, 2027
Est. primary completion date July 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Diagnosis of candidemia and/or invasive candidiasis defined by: - A culture positive for yeast or Candida species, a positive Gram stain (or other method of direct microscopy) for yeast from blood or specimen from a normally sterile site, or a positive result for Candida using a Sponsor-approved rapid diagnostic test from a blood sample. - Presence of one or more clinical criteria attributable to candidemia/invasive candidiasis: fever, hypothermia, hypotension, tachypnea ,tachycardia, and local signs associated with organ/site infected with Candida, and/or radiologic findings suggesting invasive candidiasis. Exclusion Criteria: - Existing infections including: infections due to Candida krusei (in blood or any other normally sterile site), inappropriate fungal infection source control, diagnosis of certain deep-seated Candida infections, or temporally related proven bacterial infection at the same or contiguous infection site. - Requirement, or expected requirement, for hemodialysis - Received greater than 2 days equivalent of prior systemic antifungal treatment to treat the current episode of candidemia, within the 96 hours before to study enrolment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fosmanogepix
IV infusion
Fosmanogepix
Oral tablet
Caspofungin
IV infusion
Fluconazole
Fluconazole oral capsule
Placebo
Matching placebo for caspofungin (IV infusion)
Placebo
Matching placebo for fluconazole (oral capsule)
Placebo
Matching placebo for fosmanogepix (IV infusion)
Placebo
Matching placebo for fosmanogepix (oral tablet)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basilea Pharmaceutica

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants alive- United States Food and Drug Administration (US FDA) Day 30
Primary Proportion of participants with an overall response of Treatment Success- European Medicines Agency (EMA) End of study treatment (EOST) (up to Day 42)
Secondary Proportion of participants alive (EMA) Day 30
Secondary Proportion of participants with an overall response of Treatment Success (US FDA) EOST (up to Day 42)
Secondary Proportion of participants with an overall response of Treatment Success Day 14
Secondary Proportion of participants with an overall response of Treatment Success End of IV treatment (EOIV) (up to Day 42)
Secondary Proportion of participants with an overall response of Treatment Success (sustained) at follow up visit 6 weeks after EOST (up to 12 weeks)
Secondary Proportion of participants with Clinical response of Success Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST
Secondary Proportion of participants with Mycological response of Eradication or Presumed Eradication Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST
Secondary Time to first negative blood culture in participants on fosmanogepix compared to caspofungin/fluconazole Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Secondary Incidence of treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), and treatment-related adverse events (AEs) and AEs leading to discontinuation Screening up to 28 days after the last dose of study drug (approximately up to 14 Weeks)
Secondary Number of Participants With Laboratory Abnormalities Baseline up to follow-up 6-weeks after EOST (approximately up to 12 weeks)
Secondary Assessment of 12-lead electrocardiogram (ECGs) Baseline up to follow-up 6-weeks after EOST (approximately up to 12 weeks)
Secondary Number of Participants With Abnormal Neurological Examination Findings Baseline up to follow-up 6-weeks after EOST (approximately up to 12 weeks)
Secondary Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) Day 3: 0, 3, 6, 9 and 24 hours post-dose; Day 7, 14, 21, 28, 35; EOST: 72 and 192 hours post-dose
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