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Antifungal Therapy Duration for Candidemia in Children (COUNT Trial)

N/A

Recruiting

Led By Brian Fisher, DO

Research Sponsored by Arkansas Children's Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the measures assigned on day 14 will inform the primary analysis for the primary objective

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare short- and standard-course antifungal therapies in kids with uncomplicated candidemia to see if shorter durations are as effective.

Who is the study for?

This trial is for children older than 120 days and younger than 18 years with a specific yeast infection in the blood, who've had successful initial treatment. They must not have other severe infections or conditions that require ongoing antifungal drugs, and girls of childbearing age must not be pregnant.

What is being tested?

Researchers are testing if treating pediatric patients with uncomplicated candidemia for an additional 7 days after an initial week of therapy is better or equal to stopping treatment. The study randomly assigns participants to either continue or stop therapy after the first week.

What are the potential side effects?

While specific side effects aren't listed here, antifungal treatments can typically include nausea, diarrhea, stomach pain, rash, and potential liver problems. The severity varies from patient to patient.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the measures assigned on day 14 will inform the primary analysis for the primary objective

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the measures assigned on day 14 will inform the primary analysis for the primary objective

This trial's timeline: 3 weeks for screening, Varies for treatment, and the measures assigned on day 14 will inform the primary analysis for the primary objective for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare the desirability of outcome ranking (DOOR) in short-course vs standard-course arm

Secondary study objectives

Compare the DOOR for subjects with a negative vs positive T2 Candida® biomarker at day 7

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Short-course therapyExperimental Treatment1 Intervention

pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy

Group II: Standard-course therapyActive Control1 Intervention

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

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