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) versus no additional ant
| Condition(s) | Invasive Candidiasis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 w |
| Who can participate | 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 randomiz |
| Ages | 120 Days |
| Sex | All |
| Lead sponsor | Arkansas Children's Hospital Research Institute |
| Locations | 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 (+16 more sites) |
| Start date | 2023-09-08 |
| NCT ID | NCT05763251 |
| Official listing | https://clinicaltrials.gov/study/NCT05763251 |