Invasive CandidiasisCOUNTNCT05763251
Comparison of Uncomplicated Candidemia Therapy Duration in Children
A study testing therapy duration in people with Invasive Candidiasis, run by Arkansas Children's Hospital Research Institute at 22 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 120 days and older
- Conditions the study is for
- Invasive Candidiasis
- What is being tested?
- therapy duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 8 Sep 2023to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 120 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 120 days at the time of the first negative blood culture at any participating site;
- Candidemia with at least one positive blood culture for any Candida spp;
- 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);
- Sustained clearance of Candida spp. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization;
- Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization;
- Between the onset of qualifying candidemia and randomization, no suspicion of disseminated candidiasis by patient's clinical team or, if deemed clinically necessary, documented negative radiological imaging such as an abdominal ultrasound or abdominal CT scan.
Who cannot join
- Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease;
- Neutropenic (absolute neutrophil count < 500 cells/µl) at the time of enrollment or anticipated to be neutropenic in the week following randomization;
- Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease;
- Previous enrollment in this trial;
- Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission;
- A documented DNR order;
- Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 2 countries
United States21 sites, 21 recruiting
- Recruiting
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 31193
- Recruiting
Dell Children's Medical Center
Austin, Texas, 78723
- Recruiting
Children's Hospital of Alabama
Birmingham, Alabama, 35233
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Comer Children's Hospital
Chicago, Illinois, 60637
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Duke Children's Hospital
Durham, North Carolina, 27705
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46202
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Yale New Haven Children's Hospital
New Haven, Connecticut, 06510
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Syd Shuster, 267-425-1462, shusters@chop.edu
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
- Recruiting
Washington University St. Louis
St Louis, Missouri, 63130
Australia1 site, 1 recruiting
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6009
About this study
Official title: Short Course Versus Standard Course Antifungal Therapy for Uncomplicated Candidemia in Children and Adolescents: A Multi-Center Randomized Controlled Trial
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.
Read the detailed description
The primary objective of this study will be addressed with a multi-center open label randomized controlled trial designed to 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. The secondary objective of this study is an embedded observational biomarker study. This objective will determine if the novel T2Candida® biomarker performed at the time of randomization (i.e. Day 7 of systemic antifungal therapy) will be associated with patient outcomes assessed at Day 14. The results of the T2Candida® biomarker will not be available in real-time and thus will not impact the primary study objective. Eligible patients will be any hospitalized patient at a participating center with uncomplicated candidemia that is older than 120 days and <18 years of age at time of candidemia onset. Patients need to receive an echinocandin as their primary antifungal therapy for at least three days and continue systemic antifungal therapy (either with an echinocandin or step-down to an azole) for a total of 7 days from their first negative blood culture and have no evidence of metastatic foci of candidemia at the time of randomization. Patients with neutropenia or anticipated to have neutropenia during the study follow-up window will not be eligible. Patients can only be enrolled to the study once. This study population will serve as the source cohort for both study objectives. Patients will be randomized 1:1 to one of two study arms, short-course therapy or standard-course therapy. Patients will be followed for 21 days from the day of randomization (Day 7 to Day 28) to capture primary and secondary outcome measures.
- Conditions
- Invasive Candidiasis
- Being tested
- therapy duration
- Medical subject headings
- Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapy durationOther
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 group | Role | What they receive |
|---|---|---|
| Short-course therapy | Experimental | pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy Receives: Other: therapy duration |
| Standard-course therapy | No 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the desirability of outcome ranking (DOOR) in short-course vs standard-course arm
The primary analysis for the primary objective will compare the DOOR distributions at 7 days from randomization (i.e., outcome assessment on Day 14 from first negative blood culture) between subjects from the two study groups, based on randomized treatment assignments, in accordance with the intention-to-treat principle. The primary analysis will use the DOORs assigned on this day to assess which therapy course is better, short-course or standard-course.
Measured: The measures assigned on Day 14 will inform the primary analysis for the primary objective
Secondary outcomes (1)
Compare the DOOR for subjects with a negative vs positive T2 Candida® biomarker at day 7
The results of the Day 7 T2Candida® biomarker (i.e. detected versus not detected) and the randomization group (i.e. short-course versus standard-course) will allow for the following four subsets of patients: 1. Patient is randomized to short-course group and has a not-detected result for the T2Candida® biomarker at time of randomization; 2. patient is randomized to short-course group and has a detected T2Candida® biomarker at time of randomization; 3. patient is randomized to standard-course group and has a not-detected result for the T2Candida® biomarker at time of randomization; 4. patient is randomized to standard-course group and has a detected T2Candida® biomarker at time of randomization. This analysis will compare the DOOR categories between the first two groups (i.e. short-course and not-detected versus short-course and detected) and then be repeated for the second two groups (i.e. standard-course and not detected versus standard-course and detected).
Measured: The DOOR measure on Day 14 will be used for the primary analysis for the secondary objective.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start8 Sep 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Westat, St. Jude Children's Research Hospital, George Washington University, Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Brian Fisher, DO, Principal investigator, Children's Hospital of PhiladelphiaWilliam J Steinbach, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763251
- Sponsor's protocol ID
- 22-020057
- Other IDs
- 1R01AI170385-01
- Acronym
- COUNT
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course Versus Standard Course Antifungal Therapy for Uncomplicated Candidemia in Children and Adolescents: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05763251
- Acronym / sponsor ID
- COUNT / 22-020057
- Conditions
- Invasive Candidiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Westat, St. Jude Children's Research Hospital, George Washington University, Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study will be addressed with a multi-center open label randomized controlled trial designed to 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. The secondary objective of this study is an embedded observational biomarker study. This objective will determine if the novel T2Candida® biomarker performed at the time of randomization (i.e. Day 7 of systemic antifungal therapy) will be associated with patient outcomes assessed at Day 14. The results of the T2Candida® biomarker will not be available in real-time and thus will not impact the primary study objective. Eligible patients will be any hospitalized patient at a participating center with uncomplicated candidemia that is older than 120 days and <18 years of age at time of candidemia onset. Patients need to receive an echinocandin as their primary antifungal therapy for at least three days and continue systemic antifungal therapy (either with an echinocandin or step-down to an azole) for a total of 7 days from their first negative blood culture and have no evidence of metastatic foci of candidemia at the time of randomization. Patients with neutropenia or anticipated to have neutropenia during the study follow-up window will not be eligible. Patients can only be enrolled to the study once. This study population will serve as the source cohort for both study objectives. Patients will be randomized 1:1 to one of two study arms, short-course therapy or standard-course therapy. Patients will be followed for 21 days from the day of randomization (Day 7 to Day 28) to capture primary and secondary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-course therapy | Experimental | Other: therapy durationpediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy |
| Standard-course therapy | No 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 |
Who may qualify
- Ages
- 120 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 120 days at the time of the first negative blood culture at any participating site;
- Candidemia with at least one positive blood culture for any Candida spp;
- 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);
- Sustained clearance of Candida spp. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization;
- Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization;
Key exclusion criteria (7 listed)
- Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease;
- Neutropenic (absolute neutrophil count < 500 cells/µl) at the time of enrollment or anticipated to be neutropenic in the week following randomization;
- Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease;
- Previous enrollment in this trial;
- Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapy durationthe standard-course arm will receive 14 days total of antifungal therapy and the short-course arm will only receive 7 days of therapy | Other | Short-course therapy |
Primary outcome
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
The primary analysis for the primary objective will compare the DOOR distributions at 7 days from randomization (i.e., outcome assessment on Day 14 from first negative blood culture) between subjects from the two study groups, based on randomized treatment assignments, in accordance with the intention-to-treat principle. The primary analysis will use the DOORs assigned on this day to assess which therapy course is better, short-course or standard-course.
1 secondary outcome
Compare the DOOR for subjects with a negative vs positive T2 Candida® biomarker at day 7
Time frame: The DOOR measure on Day 14 will be used for the primary analysis for the secondary objective.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Fisher, DO principal investigator
Children's Hospital of Philadelphia
William J Steinbach, MD principal investigator
Arkansas Children's Hospital Research Institute
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapy duration in people with Invasive Candidiasis, run by Arkansas Children's Hospital Research Institute at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah K Johnson, PhD (501-364-3057, skjohnson@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.