Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05421858 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 144 to 146v36
  2. Site details revised at 1 of 144 sitesv35
  3. Study sites: 143 to 144v34
  4. Study sites: 142 to 143v33
  5. Trial sites expanded: 138 → 142 locationsv32
  6. Trial sites expanded: 130 → 138 locationsv31
  7. Study sites: 122 to 130v30
  8. Study sites: 110 to 122v29
  9. Study sites: 105 to 110v28
  10. Study sites: 104 to 105v27
  11. Study sites: 103 to 104v26
  12. Study sites: 100 to 103v25
  13. Study sites: 93 to 100v24
  14. Study sites: 86 to 93v23
  15. Study sites: 80 to 86v22
  16. Study sites: 70 to 80v21
  17. Study sites: 50 to 70
    • Eligibility criteria expanded, about 85 words
    • Secondary endpoints: 11 to 12
    v20
  18. Study sites: 36 to 50v19
  19. Study sites: 27 to 36v18
  20. Study sites: 12 to 27v17
  21. Study sites: 7 to 12v16
  22. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2024 to Dec 11, 2024
    • Site details revised at 7 of 7 sites
    v15
  23. Start date: Nov 30, 2024 to Dec 30, 2024
    • Study sites: 3 to 7
    v14
  24. Start date: Oct 30, 2024 to Nov 30, 2024
    • Study sites: 1 to 3
    • Collaborators expanded, about 6 words
    v13
  25. Start date: Aug 23, 2024 to Oct 30, 2024
    • Study sites: 0 to 1
    v12
  26. Primary and study completion dates: Jul 15, 2027 to Jan 30, 2028v11 Show 5 more changesShow less
    • Start date: Jul 15, 2024 to Aug 23, 2024
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 265 words
    • Secondary endpoints: 13 to 11
    • Study title revised
  27. Lead sponsor: Pfizer to Basilea Pharmaceuticav10 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Interventions: Caspofungin (Drug), Fluconazole (Drug), PF-07842805 (Drug), PF-07842805 (Drug), Placebo (Drug), Placebo (Drug) to Caspofungin (Drug), Fluconazole (Drug), Fosmanogepix (Drug), Fosmanogepix (Drug), Placebo (Drug), Placebo (Drug), Placebo (Drug), Placebo…
    • Secondary endpoints revised (13)
    • Study title expanded, about 2 words
  28. Re-verified, no change to tracked fieldsv9
  29. Primary and study completion dates: Oct 7, 2026 to Jul 15, 2027
    • Start date: Oct 1, 2023 to Jul 15, 2024
    v8
  30. Start date: Aug 1, 2023 to Oct 1, 2023v7
  31. Start date: Jun 1, 2023 to Aug 1, 2023
    • Primary and study completion dates: Aug 7, 2026 to Oct 7, 2026
    v6
  32. Start date: Apr 1, 2023 to Jun 1, 2023
    • Primary and study completion dates: Feb 10, 2026 to Aug 7, 2026
    v5
  33. Start date: Feb 1, 2023 to Apr 1, 2023v4
  34. Start date: Dec 5, 2022 to Feb 1, 2023v3
  35. Secondary endpoints: details revised at 7 of 13 entriesv2
  36. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05421858
Lead Sponsor Basilea Pharmaceutica
Collaborators: Biomedical Advanced Research and Development Authority
Conditions
(from sponsor)		 Candidemia, Candidiasis, Invasive
Related terms Candidemia, Candidiasis, Invasive, Mycoses, Torulopsis
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov