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Tests treatment safety and results for Candidemia
Official title A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
ClinicalTrials.gov ID: NCT05421858
What this study is testing
What is Fosmanogepix?
Fosmanogepix is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for candidemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients ≥ 18 years (or the minimum country-specific age of consent if \> 18) at Screening who have provided signed informed consent indicating that...
- Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization...
- Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices...
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis...
- Patients with known human immunodeficiency virus infection, who have CD4+ count \ 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 (e.g., \> 2 doses of a once daily...
- 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).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Roanoke, Virginia, United States
+ 91 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Atlanta, Georgia, United States; Augusta, Georgia, United States and 105 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.