- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827694
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections (DOMINIC)
January 29, 2024 updated by: Arkansas Children's Hospital Research Institute
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: PFN Central Coordinator
- Phone Number: 501-364-3057
- Email: PFNClinical@uams.edu
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1E8
- Recruiting
- The Hospital for Sick Children
-
-
-
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Recruiting
- Arkansas Children's Research Institute
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California
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La Jolla, California, United States, 92093
- Recruiting
- Rady Children's Hospital, UCSD
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Palo Alto, California, United States, 94305
- Recruiting
- Lucile Packard Children's Hospital, Stanford University
-
San Francisco, California, United States, 94143
- Withdrawn
- University of California San Francisco, Benioff Children's Hospital
-
-
Connecticut
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New Haven, Connecticut, United States, 06520
- Recruiting
- Yale University
-
-
District of Columbia
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Washington, District of Columbia, United States, 20010-2916
- Recruiting
- Children's National Hospital
-
-
Florida
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Saint Petersburg, Florida, United States, 33701
- Withdrawn
- All Children's Research Institute
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University-Children's Healthcare of Atlanta (CHOA)
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Medicine, Comer Children's
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Indiana
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Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02241
- Recruiting
- Boston Children's Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Terminated
- University of Minnesota Medical School
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Saint Paul, Minnesota, United States, 55102
- Recruiting
- Children's Minnesota
-
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Missouri
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Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy
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Saint Louis, Missouri, United States, 63110
- Recruiting
- The Washington University
-
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Nebraska
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Omaha, Nebraska, United States, 68114
- Recruiting
- Children's Omaha
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New York
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New York, New York, United States, 10021
- Recruiting
- Weil Cornell Medical College
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North Carolina
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Durham, North Carolina, United States, 27710
- Terminated
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, United States, 44195
- Withdrawn
- Cleveland Clinic
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Columbus, Ohio, United States, 43205-2664
- Recruiting
- Nationwide Children's Hospital
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Recruiting
- The Children's Hospital of Philadelphia
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Tennessee
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Memphis, Tennessee, United States, 38105
- Recruiting
- St. Jude Children's Research Hospital
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Nashville, Tennessee, United States, 37232
- Recruiting
- Monroe Carell Jr. Children's Hospital at Vanderbilt
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Texas
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Austin, Texas, United States, 78705
- Recruiting
- Ascension Seton Medical Center
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Dallas, Texas, United States, 75390
- Recruiting
- University of Texas Southwest Medical Center (UTSW)
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Houston, Texas, United States, 77030
- Recruiting
- MD Anderson
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Washington
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Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Research Institute
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients receiving care at a participating study site
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with possible PIFI
|
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI
Time Frame: Baseline
|
Baseline
|
Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI
Time Frame: Baseline
|
Baseline
|
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI
Time Frame: Baseline
|
Baseline
|
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
Baseline
|
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI
Time Frame: Baseline
|
Baseline
|
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 49 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Brian Fisher, Children's Hospital of Philadelphia
- Principal Investigator: William Steinbach, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2018
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
January 31, 2019
First Submitted That Met QC Criteria
January 31, 2019
First Posted (Actual)
February 1, 2019
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00094558
- R01AI139032 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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