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

NCT06907992 | Not Yet Recruiting FDA Drug

• 2 other identifiers: MSG 23U01CK000692
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Candidemia

Keywords

candidemia; uncomplicated candidemia; antifungal therapy; echinocandin; caspofungin; micafungin; rezafungin; anidulafungin

Outcome Measures

Primary Outcomes (1)

• Eradication of candida from the blood at day 7 or day 14

  Blood culture monitoring at day 7 and day 14

  14 Days

Study Arms (2)

7 Days

Study participants randomized to the 7 Day group will receive the short-course antifungal therapy for 7 days.

Drug: Antifungal treatment

14 Days

Study participants randomized to the 14 Day group will receive the standard of care antifungal therapy for 14 days.

Drug: Antifungal treatment

Interventions

Antifungal treatment DRUG

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

14 Days; 7 Days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine

MeSH Terms

Conditions

Candidemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose Vazquez, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aprile Osborn, MSN

CONTACT

706-721-0309; aosborn@augusta.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 3, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)