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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI139032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with possible PIFI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive Testing for PIFI | Diagnostic Test | galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq |
|
| Measure | Description | Time Frame |
|---|---|---|
| Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI | Baseline | |
| Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI | Baseline | |
| Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI | Baseline | |
| Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI | Baseline | |
| Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a positive result among subjects determined to have PIFI | Baseline | |
| Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a negative result among subjects determined not to have PIFI | Baseline | |
| Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI | Baseline | |
| Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure | Outcome score inclusive of outcomes and adverse events. Comprehensive clinical outcome score from most to least desirable are score of 1 (survival, improvement in pulmonary nodules, no adverse events related to anti-fungal therapy or invasive diagnostic intervention) to score of 7 (death) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving care at a participating study site
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PFN Central Coordinator | Contact | 501-364-3057 | PFNClinical@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| William Steinbach | University of Arkansas | Principal Investigator |
| Brian Fisher | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Research Institute | Recruiting | Little Rock | Arkansas | 72202 | United States | |
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blood
| 49 days |
| Rady Children's Hospital, UCSD |
| Recruiting |
| La Jolla |
| California |
| 92093 |
| United States |
| Children's Hospital of Orange County | Recruiting | Orange | California | 92868 | United States |
| Lucile Packard Children's Hospital, Stanford University | Recruiting | Palo Alto | California | 94305 | United States |
| University of California San Francisco, Benioff Children's Hospital | Withdrawn | San Francisco | California | 94143 | United States |
| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States |
| Children's National Hospital | Recruiting | Washington D.C. | District of Columbia | 20010-2916 | United States |
| All Children's Research Institute | Active, not recruiting | St. Petersburg | Florida | 33701 | United States |
| Emory University-Children's Healthcare of Atlanta (CHOA) | Recruiting | Atlanta | Georgia | 30322 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
| University of Chicago Medicine, Comer Children's | Recruiting | Chicago | Illinois | 60637 | United States |
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02241 | United States |
| University of Minnesota Medical School | Active, not recruiting | Minneapolis | Minnesota | 55455 | United States |
| Children's Minnesota | Recruiting | Saint Paul | Minnesota | 55102 | United States |
| Children's Mercy | Recruiting | Kansas City | Missouri | 64108 | United States |
| The Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| Children's Omaha | Recruiting | Omaha | Nebraska | 68114 | United States |
| Weil Cornell Medical College | Recruiting | New York | New York | 10021 | United States |
| Duke University Medical Center | Active, not recruiting | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Withdrawn | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205-2664 | United States |
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
| The Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19146 | United States |
| St. Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Recruiting | Nashville | Tennessee | 37232 | United States |
| Ascension Seton Medical Center | Recruiting | Austin | Texas | 78705 | United States |
| University of Texas Southwest Medical Center (UTSW) | Recruiting | Dallas | Texas | 75390 | United States |
| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
| Seattle Children's Research Institute | Recruiting | Seattle | Washington | 98105 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1E8 | Canada |
| ID | Term |
|---|---|
| D055744 | Invasive Pulmonary Aspergillosis |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
| D008172 | Lung Diseases, Fungal |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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