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Antifungal Therapy Duration for Candidemia in Children (COUNT Trial)

Orange, CA
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.

See full description
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.See study design
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 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

Find a Location

Closest Location:Cincinnati Children's Hospital· Cincinnati, OH· 97 miles
Image of Cincinnati Children's Hospital in Cincinnati, United States.Image of Cincinnati Children's Hospital in Cincinnati, United States.Image of Cincinnati Children's Hospital in Cincinnati, United States.

Who is running the clinical trial?

George Washington UniversityOTHER
262 Previous Clinical Trials
475,111 Total Patients Enrolled
Arkansas Children's Hospital Research InstituteLead Sponsor
140 Previous Clinical Trials
5,024,625 Total Patients Enrolled
St. Jude Children's Research HospitalOTHER
450 Previous Clinical Trials
5,326,063 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
744 Previous Clinical Trials
11,404,197 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,358 Previous Clinical Trials
5,514,808 Total Patients Enrolled
WestatOTHER
48 Previous Clinical Trials
39,283 Total Patients Enrolled
Brian Fisher, DOPrincipal InvestigatorChildren's Hospital of Philadelphia
William J Steinbach, MDPrincipal InvestigatorArkansas Children's Hospital Research Institute
3 Previous Clinical Trials
3,934 Total Patients Enrolled

Media Library

therapy duration Clinical Trial Eligibility Overview. Trial Name: NCT05763251 — N/A
Invasive Candidiasis Research Study Groups: Standard-course therapy, Short-course therapy
Invasive Candidiasis Clinical Trial 2023: therapy duration Highlights & Side Effects. Trial Name: NCT05763251 — N/A
therapy duration 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763251 — N/A
~280 spots leftby Jun 2030
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