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NCT Number: NCT06907992

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

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.

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Key information

Conditions

Candidemia Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Augusta University

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antifungal treatment

Drug

Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)

Primary outcomes

  1. Eradication of candida from the blood at day 7 or day 14

    Time frame: 14 Days

    Blood culture monitoring at day 7 and day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Aprile Osborn, MSN

CONTACT

[email protected]

706-721-0309

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Acronym: SCAT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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