Actively Recruiting

Phase Not Applicable
Age: 120Days +
All Genders
NCT05763251

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

Age: 120Days +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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