Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Pulmonary Invasive Aspergillosis Clinical Trial

— DOMINIC  

Official title:

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827694
• Other study ID #: Pro00094558
• Secondary ID: R01AI139032
• Status: Recruiting
• Start date: October 30, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: PFN Central Coordinator
• Phone: 501-364-3057
• Email: PFNClinical[@]uams.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 120 Days to 21 Years

Eligibility

Inclusion Criteria:

• Males or females age > 120 days and < 22 years at any participating site

• Have at least one of the following conditions associated with a known high incidence of IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrow failure, primary or acquired immune deficiency, or malignancy

• New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a wedge-shaped and segmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign

• Prolonged neutropenia (absolute neutrophil count < 500 cells/µl for a period of = 5 consecutive days) in 30 days prior to and including the day of qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because of underlying acquired or primary immune deficiency (e.g. chronic granulomatous disease) on the date of the qualifying chest MRI or CT scan

• Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

• Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw

• Previous inclusion in this study

Related Conditions & MeSH terms

• Aspergillosis
• Communicable Diseases
• Infections
• Invasive Fungal Infections
• Invasive Pulmonary Aspergillosis
• Mycoses
• Pulmonary Invasive Aspergillosis

Intervention

Diagnostic Test:
• Non-Invasive Testing for PIFI
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Emory University-Children's Healthcare of Atlanta (CHOA)	Atlanta	Georgia
United States	Ascension Seton Medical Center	Austin	Texas
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	University of Chicago Medicine, Comer Children's	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwest Medical Center (UTSW)	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Children's Mercy	Kansas City	Missouri
United States	Rady Children's Hospital, UCSD	La Jolla	California
United States	Arkansas Children's Research Institute	Little Rock	Arkansas
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Weil Cornell Medical College	New York	New York
United States	Children's Omaha	Omaha	Nebraska
United States	Lucile Packard Children's Hospital, Stanford University	Palo Alto	California
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	The Washington University	Saint Louis	Missouri
United States	Children's Minnesota	Saint Paul	Minnesota
United States	All Children's Research Institute	Saint Petersburg	Florida
United States	University of California San Francisco, Benioff Children's Hospital	San Francisco	California
United States	Seattle Children's Research Institute	Seattle	Washington
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI		Baseline
Primary	Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI		Baseline
Primary	Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI		Baseline
Primary	Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI		Baseline
Primary	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
Primary	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
Primary	Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI		Baseline
Primary	Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI		Baseline
Secondary	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)	49 days