RECRUITING

Comparison of Uncomplicated Candidemia Therapy Duration in Children

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Conditions

Invasive Candidiasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Short Course Versus Standard Course Antifungal Therapy for Uncomplicated Candidemia in Children and Adolescents: A Multi-Center Randomized Controlled Trial

Quick Facts

Study Start:2023-09-08
Study Completion:2032-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05763251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:120 Days to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \> 120 days and \< 18 years at the time of positive blood culture at any participating site;
  2. 2. Candidemia with at least one positive blood culture for any Candida spp;
  3. 3. Receiving/received an echinocandin (caspofungin, micafungin or anidulafungin) as primary antifungal therapy for candidemia for at least 3 days from day of first negative culture with continuation of uninterrupted systemic antifungal therapy at the time of enrollment);
  4. 4. Sustained clearance of Candida spp. from repeat blood culture(s) obtained on or before day of randomization;
  5. 5. Partial or complete clinical response, as defined by published guidelines, on or before day of randomization;
  6. 6. No evidence of metastatic foci of infection at the time of randomization, as documented by a negative abdominal ultrasound or abdominal CT scan of the liver, spleen, and kidneys and negative ophthalmologic examination.
  1. 1. Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease;
  2. 2. Neutropenic (absolute neutrophil count \< 500 cells/μl) at the time of enrollment or anticipated to be neutropenic in the week following randomization;
  3. 3. Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease;
  4. 4. Previous enrollment in this trial.
  5. 5. Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission

Contacts and Locations

Study Contact

Sarah K Johnson, PhD
CONTACT
501-364-3057
skjohnson@uams.edu
Sydney Shuster, MPH
CONTACT
267-425-1462
shusters@chop.edu

Principal Investigator

Brian Fisher, DO
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
William J Steinbach, MD
PRINCIPAL_INVESTIGATOR
Arkansas Children's Hospital Research Institute

Study Locations (Sites)

Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Comer Children's Hospital
Chicago, Illinois, 60637
United States
Riley Children's Hospital
Indianapolis, Indiana, 46202
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Washington University St. Louis
Saint Louis, Missouri, 63130
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Dell Children's Medical Center
Austin, Texas, 78723
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States

Collaborators and Investigators

Sponsor: Arkansas Children's Hospital Research Institute

  • Brian Fisher, DO, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
  • William J Steinbach, MD, PRINCIPAL_INVESTIGATOR, Arkansas Children's Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-08
Study Completion Date2032-06-30

Study Record Updates

Study Start Date2023-09-08
Study Completion Date2032-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Invasive Candidiasis