A Study Comparing Short-course Antifungal Therapy (SCAT)... | NCT06907992

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

NCT06907992

Sponsor

Augusta University

Status

Not yet recruiting

Last Update Posted

Apr 4, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Candidemia

Interventions

Antifungal treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U01CK000692	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2025Estimated

Primary Completion Date

May 1, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Mar 25, 2025

First Submission Date that Met QC Criteria

Apr 1, 2025

First Posted Date

Apr 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2025

Last Update Posted Date

Apr 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Antifungal treatment	Drug	Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)	14 Days 7 Days

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

ID	Term
D058365	Candidiasis, Invasive
D002177	Candidiasis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses