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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Candidemia
• Intervention / Treatment: Drug: Antifungal treatment

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Aprile Osborn, MSN; Phone Number: 706-721-0309; Email: aosborn@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants will be recruited from:

A. Inpatient settings based on positive blood cultures for candidemia. B. Daily review of microbiology labs C. Referrals from investigators, ICUs and hospital unit personnel

Description

Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.
3. Received < 5 days of prior antifungal therapy
4. Informed Consent for randomization
5. 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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
7 Days; Study participants randomized to the 7 Day group will receive the short-course antifungal therapy for 7 days.	Drug: Antifungal treatment; Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)
14 Days; Study participants randomized to the 14 Day group will receive the standard of care antifungal therapy for 14 days.	Drug: Antifungal treatment; Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication of candida from the blood at day 7 or day 14	Blood culture monitoring at day 7 and day 14	14 Days

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Jose Vazquez, MD, Augusta University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: candidemia; caspofungin; micafungin; antifungal therapy; anidulafungin; echinocandin; rezafungin; uncomplicated candidemia
• Additional Relevant MeSH Terms: Invasive Fungal Infections; Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Mycoses; Candidiasis, Invasive; Candidiasis; Fungemia; Candidemia; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Anti-Infective Agents, Local; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; 14-alpha Demethylase Inhibitors; Antifungal Agents; Clotrimazole; Miconazole
• Other Study ID Numbers: MSG 23; U01CK000692 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No