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Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections (DOMINIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827694
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : March 29, 2022
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Study Description
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Brief 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).

Condition or disease Intervention/treatment
Pulmonary Invasive Fungal Infections Pulmonary Invasive Aspergillosis Diagnostic Test: Non-Invasive Testing for PIFI

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with possible PIFI Diagnostic Test: Non-Invasive Testing for PIFI
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq


Outcome Measures
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Primary Outcome Measures :
  1. Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]
  2. Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI [ Time Frame: Baseline ]
  3. Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]
  4. Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI [ Time Frame: Baseline ]
  5. 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 ]
  6. 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 ]
  7. Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]
  8. 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 ]

Secondary Outcome Measures :
  1. 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)


Biospecimen Retention:   Samples With DNA
blood

Eligibility Criteria
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Ages Eligible for Study:   120 Days to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving care at a participating study site
Criteria

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, or hematologic 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 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 qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827694


Contacts
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Contact: PFN Central Coordinator 919-668-4847 PFNClinical@duke.edu

Locations
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Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: William Steinbach Duke University
Principal Investigator: Brian Fisher Children's Hospital of Philadelphia
More Information
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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03827694    
Other Study ID Numbers: Pro00094558
R01AI139032 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Mycoses
Aspergillosis
Invasive Fungal Infections
Invasive Pulmonary Aspergillosis
Disease Attributes
 Pathologic Processes
Bacterial Infections and Mycoses
Pulmonary Aspergillosis
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases