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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 : January 30, 2020
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive mold infection (PIMI).

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

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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, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIMI [ Time Frame: Baseline ]
  2. Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIMI [ Time Frame: Baseline ]
  3. Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIMI [ Time Frame: Baseline ]
  4. Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIMI [ Time Frame: Baseline ]
  5. Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a mold pathogen to return a positive result among subjects determined to have PIMI [ Time Frame: Baseline ]
  6. Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a mold pathogen to return a negative result among subjects determined not to have PIMI [ Time Frame: Baseline ]
  7. Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIMI [ 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 PIMI [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Composite outcome score between patients with possible pulmonary invasive mold 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-mold therapy or invasive diagnostic intervention) to score of 7 (death)


Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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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 IMI: 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

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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United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Not yet recruiting
Chicago, Illinois, United States, 60611
University of Chicago Medicine, Comer Children's Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
United States, Missouri
Children's Mercy Recruiting
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Not yet recruiting
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Duke University
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
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Responsible Party: Duke University
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: January 30, 2020
Last Verified: January 2020

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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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Infection
Communicable Diseases
Aspergillosis
Invasive Pulmonary Aspergillosis
Mycoses
Pulmonary Aspergillosis
Invasive Fungal Infections
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases