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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

COUNT Trial 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.Check my eligibility

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.

COUNT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

COUNT 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

George Washington UniversityOTHER

243 Previous Clinical Trials

453,354 Total Patients Enrolled

Arkansas Children's Hospital Research InstituteLead Sponsor

135 Previous Clinical Trials

5,028,945 Total Patients Enrolled

St. Jude Children's Research HospitalOTHER

428 Previous Clinical Trials

5,306,193 Total Patients Enrolled

Media Library

therapy duration Clinical Trial Eligibility Overview. Trial Name: NCT05763251 — N/A

Invasive Candidiasis Research Study Groups: Short-course therapy, Standard-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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted into the research trial at this time?

"According to clinicaltrials.gov, this medical research has been actively recruiting since September 1st 2023 and was recently updated on July 12th of the same year."

Answered by AI

How many people are enrolled as participants in this experiment?

"Affirmative, clinicaltrials.gov's information demonstrates that this experiment is still recruiting participants. It was posted on September 1st of 2023 and most recently revised on July 12th 2023; 420 individuals are needed from one site in total for the study to be successful."

Answered by AI

Does this trial include individuals aged 35 and above among its participants?

"Patients who are between 120 days and 18 years old will be considered as participants in this clinical trial."

Answered by AI

Who is eligible to become involved in this investigation?

"This medical trial is searching for 420 individuals with invasive candidiasis, between 120 days and 18 years of age. To be eligible to participate in the study, applicants must meet certain criteria such as being administered an echinocandin antifungal therapy for at least 3 days from day of first negative culture; sustained clearance of Candida spp., partial or complete clinical response according to published guidelines prior randomization; no evidence of metastatic foci of infection as indicated by a negative abdominal ultrasound/CT scan and ophthalmologic examination."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Uncomplicated Candidemia Therapy Duration in Children

2023. "Comparison of Uncomplicated Candidemia Therapy Duration in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763251.

All > Yeast Infection