Actively Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children
Led by Arkansas Children's Hospital Research Institute · Updated on 2026-04-17
420
Participants Needed
22
Research Sites
459 weeks
Total Duration
On this page
Sponsors
A
Arkansas Children's Hospital Research Institute
Lead Sponsor
W
Westat
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Uncomplicated Candidemia Therapy Duration in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 120 days at the time of the first negative blood culture
- At least one positive blood culture for any Candida species
- Received at least 2 days of echinocandin antifungal therapy after the first negative culture and continuing systemic antifungal therapy at enrollment
- Sustained clearance of Candida shown by negative blood cultures before randomization
- Partial or complete clinical response on or before the day of randomization
- No suspicion or evidence of disseminated candidiasis before randomization, confirmed by clinical assessment or imaging if needed
You will not qualify if you...
- Currently receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease
- Neutropenic (absolute neutrophil count < 500 cells/µl) at enrollment or expected to become neutropenic within a week after
- Having an underlying condition requiring antifungal prophylaxis when not being treated for an invasive fungal disease
- Previously enrolled in this trial
- Females of childbearing age with pregnancy or without a negative pregnancy test during current admission
- Having a documented Do Not Resuscitate (DNR) order
- Having an implantable cardiac device such as a ventricular assist device or pacemaker
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
4
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 31193
Actively Recruiting
6
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Comer Children's Hospital
Chicago, Illinois, United States, 60637
Actively Recruiting
8
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
CS Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Washington University St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
12
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
13
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
14
Duke Children's Hospital
Durham, North Carolina, United States, 27705
Actively Recruiting
15
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
16
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
17
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
Dell Children's Medical Center
Austin, Texas, United States, 78723
Actively Recruiting
19
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
20
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
21
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
22
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
S
Sarah K Johnson, PhD
CONTACT
S
Sydney Shuster, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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