Status:

NOT_YET_RECRUITING

A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia

Lead Sponsor:

Augusta University

Conditions:

Candidemia

Eligibility:

All Genders

18+ years

Brief Summary

The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in p...

Eligibility Criteria

Inclusion

  • Patients ≥ 18 years of age
  • Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.
  • Received \< 5 days of prior antifungal therapy
  • Informed Consent for randomization
  • Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.

Exclusion

  • Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).
  • Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)
  • Abnormal LFTs \> 10-fold
  • Greater than 5 days of prior antifungal therapy
  • Endovascular devices that cannot be removed.
  • Immunocompromised patients (AIDS/HIV; solid organ transplant, bone marrow transplant patients, oncology patients receiving chemotherapy, neutropenic patients (ANC of \< 1,500 cells/L
  • Neutropenic at time of consent (what does this mean)
  • Break-through candidemia (people with prior candidemia who relapsed) after treatment with antifungal therapy)
  • Unable to provide informed consent from either the patient or legally authorized authority (LAR)
  • Expected mortality within 96 hours

Key Trial Info

Start Date :

May 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06907992

Start Date

May 1 2025

End Date

December 31 2027

Last Update

April 4 2025

Active Locations (1)

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Augusta University

Augusta, Georgia, United States, 30912