Comparison of Uncomplicated Candidemia Therapy Duration in Children

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.

Conditions

Invasive Candidiasis

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Study Overview

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Study Details

Study overview

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.

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

Comparison of Uncomplicated Candidemia Therapy Duration in Children

Condition
Invasive Candidiasis
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

Chicago

Comer Children's Hospital, Chicago, Illinois, United States, 60637

Indianapolis

Riley Children's Hospital, Indianapolis, Indiana, United States, 46202

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Saint Louis

Washington University St. Louis, Saint Louis, Missouri, United States, 63130

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Cincinnati

Cincinnati Children's Hospital, Cincinnati, Ohio, United States, 45229

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Austin

Dell Children's Medical Center, Austin, Texas, United States, 78723

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age \> 120 days and \< 18 years at the time of positive 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 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. Sustained clearance of Candida spp. from repeat blood culture(s) obtained on or before day of randomization;
  • 5. Partial or complete clinical response, as defined by published guidelines, on or before day of randomization;
  • 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. 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

Ages Eligible for Study

120 Days to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2032-06-30