RecruitingNot ApplicableNCT05763251

Comparison of Uncomplicated Candidemia Therapy Duration in Children

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


Sponsor

Arkansas Children's Hospital Research Institute

Enrollment

420 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 120 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying therapy duration for people with invasive candidiasis. The study is currently recruiting participants at 22 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERtherapy 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


Locations(22)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital of Orange County

Orange, California, United States

Yale New Haven Children's Hospital

New Haven, Connecticut, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Comer Children's Hospital

Chicago, Illinois, United States

Riley Children's Hospital

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

CS Mott Children's Hospital

Ann Arbor, Michigan, United States

Washington University St. Louis

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Weill Cornell Medical College

New York, New York, United States

Duke Children's Hospital

Durham, North Carolina, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Dell Children's Medical Center

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Perth Children's Hospital

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT05763251


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