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NCT05763251 · ClinicalTrials.gov registry record · NA
Comparison of Uncomplicated Candidemia Therapy Duration in Children
A NA study of Invasive Candidiasis, sponsored by Arkansas Children's Hospital Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 420
- Enrollment target
- 17
- Study locations
NCT05763251: Recruiting NA study of Invasive Candidiasis, sponsored by Arkansas Children's Hospital Research Institute.
NCT05763251 is a NA study of Invasive Candidiasis that is actively recruiting participants, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 420 participants, above the 227-participant average among 5 other Invasive Candidiasis trials with a reported enrollment target (85% higher). The trial reports 17 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05763251, a NA study of Invasive Candidiasis, is actively recruiting participants, sponsored by Arkansas Children's Hospital Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 420 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
The primary analysis for the primary objective will compare the DOOR distributions at 7 days from randomization (i.e., outcome assessment on Day 14 from first negative blood culture) between subjects from the two study groups, based on randomized treatment assignments, in accordance with the intention-to-treat principle. The primary analysis will use the DOORs assigned on this day to assess which therapy course is better, short-course or standard-course.
Conditions Studied
Interventions
- OTHER therapy duration
Study Locations (17)
Illinois
- Lurie Children's Hospital of Chicago - Chicago
- Comer Children's Hospital - Chicago
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Nationwide Children's Hospital - Columbus
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- Children's Hospital of Orange County - Orange
Connecticut
- Yale New Haven Children's Hospital - New Haven
Indiana
- Riley Children's Hospital - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2023-09-08 |
| Est. Completion | 2032-06-30 |
| Phase | NA |
What NCT05763251 shows while recruiting
NCT05763251 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 227-participant average among 5 other Invasive Candidiasis trials with a reported enrollment target (85% higher).
The record links to 1 condition, with Invasive Candidiasis appearing as the primary indexed condition, and to 1 intervention - of which therapy duration is the first listed.
NCT05763251 lists 17 locations in 15 states (Illinois, Ohio, Alabama).
Frequently Asked Questions
What is clinical trial NCT05763251 about?
NCT05763251 is a clinical study titled "Comparison of Uncomplicated Candidemia Therapy Duration in Children". 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) ver...
What is the current status of trial NCT05763251?
This trial is currently recruiting. It is a NA study. The enrollment target is 420 participants. The study started on 2023-09-08. Estimated completion is 2032-06-30.
What conditions does trial NCT05763251 study?
This clinical trial studies the following conditions: Invasive Candidiasis.
What interventions are being tested in trial NCT05763251?
The interventions under investigation include: therapy duration (OTHER).
Who is sponsoring clinical trial NCT05763251?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05763251 being conducted?
This trial has 17 study locations across Alabama, Arkansas, California, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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