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New treatment option for Invasive Candidiasis
Official title Comparison of Uncomplicated Candidemia Therapy Duration in Children
ClinicalTrials.gov ID: NCT05763251
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 120 and older
You may be able to join 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...
- 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;
You likely 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...
- 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;
See the full eligibility criteria
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Orange, California, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, United States
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 120 days and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Orange, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.