Comparison of Uncomplicated Candidemia Therapy Duration in Children

NCT05763251 · tracked via the Priya Life Science Australia tracker

Sponsor

Arkansas Children's Hospital Research Institute

Phase

Not applicable

Started

2023-09-08

Last updated

2026-04-17

Condition(s) studied

Invasive Candidiasis

Investigational drug(s) / intervention(s)

therapy duration

therapy duration: the standard-course arm will receive 14 days total of antifungal therapy and the short-course arm will only receive 7 days of therapy

Study summary

The goal of this clinical trial is to compare antifungal therapy duration in pediatric uncomplicated candidemia. The specific aims are:

* Compare the desirability of outcome ranking in children with uncomplicated candidemia randomized to 7 additional days of antifungal therapy (standard-course) versus no additional antifungal therapy (short-course) after already receiving 7 days of echinocandin therapy.
* Compare the 14-day desirability of outcome measure for subjects with a negative and those with a positive T2Candida® biomarker at day 7 of therapy within randomized groups.

Participants meeting eligibility criteria will be approached and consented between day 5 and 7 of primary systemic antifungal therapy. On day 7 of primary systemic antifungal therapy, inclusion and exclusion criteria will again be reviewed for consented patients and those still eligible will be randomized 1:1 to the two study arms. Researchers will compare no additional antifungal therapy (short-course) versus 7 additional days of systemic antifungal therapy (standard-course) in pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy to see if shorter durations are as effective as longer durations in treating uncomplicated candidemia.

Eligibility

Sex

ALL

Min age

120 Days

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age \> 120 days at the time of the first negative blood culture at any participating site; 2. Candidemia with at least one positive blood culture for any Candida spp; 3. Receiving/received an echinocandin (caspofungin, micafungin, anidulafungin, or rezafungin) as primary antifungal therapy for candidemia for at least 2 days from day of first negative culture with continuation of uninterrupted systemic antifungal therapy at the time of enrollment); 4. Sustained clearance of Candida spp. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization; 5. Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization; 6. Between the onset of qualifying candidemia and randomization, no suspicion of disseminated candidiasis by patient's clinical team or, if deemed clinically necessary, documented negative radiological imaging such as an abdominal ultrasound or abdominal CT scan. Exclusion Criteria: 1. Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease; 2. Neutropenic (absolute neutrophil count \< 500 cells/µl) at the time of enrollment or anticipated to be neutropenic in the week following randomization; 3. Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease; 4. Previous enrollment in this trial; 5. Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission; 6. A documented DNR order; 7. Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)

Primary outcome measure(s)

Compare the desirability of outcome ranking (DOOR) in short-course vs standard-course arm — The measures assigned on Day 14 will inform the primary analysis for the primary objective
The primary analysis for the primary objective will compare the DOOR distributions at 7 days from randomization (i.e., outcome assessment on Day 14 from first negative blood culture) between subjects from the two study groups, based on randomized treatment assignments, in accordance with the intention-to-treat principle. The primary analysis will use the DOORs assigned on this day to assess which therapy course is better, short-course or standard-course.

Trial sites (22)

Facility	City	Region	Status
Children's Hospital of Alabama	Birmingham	Alabama	Recruiting
Arkansas Children's Hospital	Little Rock	Arkansas	Recruiting
Children's Hospital of Orange County	Orange	California	Recruiting
Yale New Haven Children's Hospital	New Haven	Connecticut	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	Recruiting
Lurie Children's Hospital of Chicago	Chicago	Illinois	Recruiting
Comer Children's Hospital	Chicago	Illinois	Recruiting
Riley Children's Hospital	Indianapolis	Indiana	Recruiting
Boston Children's Hospital	Boston	Massachusetts	Recruiting
CS Mott Children's Hospital	Ann Arbor	Michigan	Recruiting
Washington University St. Louis	St Louis	Missouri	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	Recruiting
Weill Cornell Medical College	New York	New York	Recruiting
Duke Children's Hospital	Durham	North Carolina	Recruiting
Cincinnati Children's Hospital	Cincinnati	Ohio	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	Recruiting
Dell Children's Medical Center	Austin	Texas	Recruiting
University of Texas Southwestern Medical Center	Dallas	Texas	Recruiting
Primary Children's Hospital	Salt Lake City	Utah	Recruiting
Children's Hospital of Wisconsin	Milwaukee	Wisconsin	Recruiting
Perth Children's Hospital	Perth	Western Australia	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05763251 on ClinicalTrials.gov ↗ ← All trials in Australia