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Not yet recruiting NCT06907992

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

Observational Candidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antifungal treatment.
Who it may be relevant to
Registry conditions: Candidemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Short-Course Antifungal Therapy vs Standard of Care (14 Day Therapy) for Uncomplicated Candidemia (SCAT)

Overview

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 patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.

Interventions

  • Drug Antifungal treatment
    Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)

Primary outcome measures

  • Eradication of candida from the blood at day 7 or day 14 [Time frame: 14 Days]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Augusta University — Augusta

Identifiers

NCT: NCT06907992 · MSG 23 · U01CK000692

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗