What this study is
The goal of this clinical trial is to compare antifungal therapy duration in uncomplicated candidemia. The specific aims are:
- Compare the desirability of outcome ranking in patients 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.
What's being tested
- therapy duration
Intervention · OTHER
the standard-course arm will receive 14 days total of antifungal therapy and the short-course arm will only receive 7 days of therapy
Study details
- Official title
- 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
- Conditions
- Invasive Candidiasis
- Enrolling
- 420 people
- Starts
- 2023-09-08
- Est. completion
- 2032-06-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 120 Days and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age > 120 days at the time of the first negative blood culture at any participating site;
- Candidemia with at least one positive blood culture for any Candida spp;
- Receiving/received an echinocandin (caspofungin, micafungin, anidulafungin, or rezafungin) as primary antifungal therapy for candidemia for at least 2 days from day of first negative culture with continuation of uninterrupted systemic antifungal therapy at the time of enrollment);
- Sustained clearance of Candida spp. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization;
- Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization;
- Between the onset of qualifying candidemia and randomization, no suspicion of disseminated candidiasis by patient's clinical team or, if deemed clinically necessary, documented negative radiological imaging such as an abdominal ultrasound or abdominal CT scan.
You can't join if
- Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease;
- Neutropenic (absolute neutrophil count < 500 cells/µl) at the time of enrollment or anticipated to be neutropenic in the week following randomization;
- Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease;
- Previous enrollment in this trial;
- Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission;
- A documented DNR order;
- Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (22)
22 openChildren's Hospital of Alabama
Birmingham, Alabama, United States
RecruitingArkansas Children's Hospital
Little Rock, Arkansas, United States
RecruitingChildren's Hospital of Orange County
Orange, California, United States
RecruitingYale New Haven Children's Hospital
New Haven, Connecticut, United States
RecruitingChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
RecruitingLurie Children's Hospital of Chicago
Chicago, Illinois, United States
RecruitingComer Children's Hospital
Chicago, Illinois, United States
RecruitingRiley Children's Hospital
Indianapolis, Indiana, United States
RecruitingBoston Children's Hospital
Boston, Massachusetts, United States
RecruitingCS Mott Children's Hospital
Ann Arbor, Michigan, United States
RecruitingWashington University St. Louis
St Louis, Missouri, United States
RecruitingUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RecruitingWeill Cornell Medical College
New York, New York, United States
RecruitingDuke Children's Hospital
Durham, North Carolina, United States
RecruitingCincinnati Children's Hospital
Cincinnati, Ohio, United States
RecruitingNationwide Children's Hospital
Columbus, Ohio, United States
RecruitingChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
- Syd Shuster · Contact267-425-1462shusters@chop.edu
RecruitingDell Children's Medical Center
Austin, Texas, United States
RecruitingUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
RecruitingPrimary Children's Hospital
Salt Lake City, Utah, United States
RecruitingChildren's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Recruiting
1 site outside the US
Perth Children's Hospital
Perth, Western Australia, Australia
Recruiting
Study team
Sponsor
Arkansas Children's Hospital Research Institute
Study ID 22-020057
Principal investigator
Brian Fisher, DO
Children's Hospital of Philadelphia
Principal investigator
William J Steinbach, MD
Arkansas Children's Hospital Research Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.