Comparison of Uncomplicated Candidemia Therapy Duration in Children

Conditions

• Invasive Candidiasis

Eligibility Criteria

Sex

ALL

Age

120 Days - N/A

Healthy Volunteers

Not accepted

Interventions

• therapy duration — 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

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.

Key Dates

Start date

Sep 8, 2023

Status verified

Apr 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2032

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Short-course therapy
  pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy
• No Intervention: Standard-course therapy
  pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive 7 additional days of systemic antifungal therapy

Primary Outcome Measure

Compare the desirability of outcome ranking (DOOR) in short-course vs standard-course arm [ Time Frame: The measures assigned on Day 14 will inform the primary analysis for the primary objective ]

Central Contacts

• Sarah K Johnson, PhD
  501-364-3057
  [email protected]
• Sydney Shuster, MPH
  267-425-1462
  [email protected]

Locations (21)

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