Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06925321 (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 Patients With Invasive Mold Infections.

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 82 to 84v20
  2. Trial sites expanded: 76 → 82 locationsv19
  3. Trial sites expanded: 68 → 76 locationsv18
  4. Trial sites expanded: 52 → 68 locationsv17
  5. Trial sites expanded: 49 → 52 locationsv16
  6. Trial sites expanded: 41 → 49 locationsv15
  7. Enrollment target: 219 to 234
    • Eligibility criteria expanded, about 3 words
    v14
  8. Study sites: 28 to 41v13
  9. Study sites: 18 to 28v12
  10. Study sites: 13 to 18v11
  11. Study sites: 8 to 13v10
  12. Study sites: 5 to 8v9
  13. Study sites: 1 to 5v8
  14. Start date changed from estimate of Aug 2025 to Aug 26, 2025v7
  15. Start date: Jul 2025 to Aug 2025v6
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v5
  17. Start date: Jun 2025 to Jul 2025v4
  18. Eligibility criteria revisedv3
  19. Re-verified, no change to tracked fieldsv2
  20. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. The patient will be assigned to one of two treatment cohorts: Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment. Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Trial Details
NCT Number NCT06925321
Lead Sponsor Basilea Pharmaceutica
Collaborators: Biomedical Advanced Research and Development Authority
Conditions
(from sponsor)		 Invasive Mold Infections
Related terms Mycoses
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov