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

Augusta University

Status: Not yet enrolling

Conditions: Candidemia

Treatments: Drug: Antifungal treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06907992

U01CK000692 (U.S. NIH Grant/Contract)

MSG 23

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

7 Days

Description:

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

Treatment:

Drug: Antifungal treatment

14 Days

Description:

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

Treatment:

Drug: Antifungal treatment