Recruiting

Short-Course vs. Standard-Course

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT05763251

Conditions

Invasive Candidiasis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

therapy duration

Study Details

Brief 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.

Conditions

Invasive Candidiasis

Study ID

NCT05763251

Start date

Sep 8, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2032

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Short-course therapy

pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy

no intervention: Standard-course therapy

pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive 7 additional days of systemic antifungal therapy

Interventions

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

Primary outcome measure

  • Compare the desirability of outcome ranking (DOOR) in short-course vs standard-course arm [ Time Frame: The measures assigned on Day 14 will inform the primary analysis for the primary objective ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Yale New Haven Children's Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 31193

Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Comer Children's Hospital

Recruiting

Chicago, Illinois, United States, 60637

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

CS Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Washington University St. Louis

Recruiting

St Louis, Missouri, United States, 63130

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Duke Children's Hospital

Recruiting

Durham, North Carolina, United States, 27705

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Dell Children's Medical Center

Recruiting

Austin, Texas, United States, 78723

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2026-04-17.