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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI170385-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Westat | OTHER |
| St. Jude Children's Research Hospital | OTHER |
| George Washington University | OTHER |
| Children's Hospital of Philadelphia |
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The goal of this clinical trial is to compare antifungal therapy duration in pediatric uncomplicated candidemia. The specific aims are:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | The measures assigned on Day 14 will inform the primary analysis for the primary objective |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah K Johnson, PhD | Contact | 501-364-3057 | skjohnson@uams.edu | |
| Sydney Shuster, MPH | Contact | 267-425-1462 | shusters@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian Fisher, DO | Children's Hospital of Philadelphia | Principal Investigator |
| William J Steinbach, MD | Arkansas Children's Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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| The DOOR measure on Day 14 will be used for the primary analysis for the secondary objective. |
| Arkansas Children's Hospital |
| Recruiting |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Children's Hospital of Orange County | Recruiting | Orange | California | 92868 | United States |
| Yale New Haven Children's Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 31193 | United States |
| Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
| Comer Children's Hospital | Recruiting | Chicago | Illinois | 60637 | United States |
| Riley Children's Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| CS Mott Children's Hospital | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| Washington University St. Louis | Recruiting | St Louis | Missouri | 63130 | United States |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
| Weill Cornell Medical College | Recruiting | New York | New York | 10065 | United States |
| Duke Children's Hospital | Recruiting | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Dell Children's Medical Center | Recruiting | Austin | Texas | 78723 | United States |
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| Primary Children's Hospital | Recruiting | Salt Lake City | Utah | 84113 | United States |
| Children's Hospital of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Perth Children's Hospital | Recruiting | Perth | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
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| ID | Term |
|---|---|
| D000081206 | Duration of Therapy |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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