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A Phase 3 efficacy and safety study of fosmanogepix for the treatment of adult participants with candidemia and/or invasive candidiasis.
EU CTIS ID: 2022-500455-23-00
What this study is testing
To evaluate the efficacy of IV followed by oral fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, by comparison to a standard-of-care regimen of IV caspofungin followed by oral fluconazole.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 1. Existing Infection a) Infection known to be due to Candida, in blood or any other normally sterile site. b) Inappropriate fungal infection source control. c) Diagnosis of certain deep-seated Candida infections.
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 1. Existing Infection a) Infection known to be due to Candida, in blood or any other normally sterile site. b) Inappropriate fungal infection source control. c) Diagnosis of certain deep-seated Candida infections.
- 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.
- 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.
- 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 medications.
- 8. Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved dose 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).
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Argentina
- Colombia
- United States
- Australia
- South Africa
- Israel
- Brazil
- Taiwan
- Singapore
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Argentina; Colombia; United States; Australia; South Africa and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.