Comparing antifungal treatment durations for children with uncomplicated candidemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of two different durations of antifungal therapy in pediatric patients diagnosed with uncomplicated candidemia. Participants will be randomized to receive either an additional 7 days of antifungal treatment or no further treatment after an initial 7 days of therapy. The study also includes an observational component that assesses the T2Candida® biomarker to evaluate its association with patient outcomes at 14 days. Eligible patients must be hospitalized children aged between 120 days and 18 years who have shown a clinical response to initial treatment and have no evidence of metastatic infection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 120 days at the time of the first negative 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, 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);
4. Sustained clearance of Candida spp. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization;
5. Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization;
6. 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.

Exclusion Criteria:

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;
6. A documented DNR order;
7. Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)

Where it's running

• Children's Hospital of Alabama
  Birmingham, Alabama, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• Yale New Haven Children's Hospital
  New Haven, Connecticut, United States Recruiting
• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Brian Fisher, DO — Children's Hospital of Philadelphia
• Study coordinator: Sarah K Johnson, PhD
• Email: skjohnson@uams.edu
• Phone: 501-364-3057

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.