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

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ClinicalTrials.gov Identifier: NCT03827694
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : December 24, 2020
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date January 31, 2019
First Posted Date February 1, 2019
Last Update Posted Date December 24, 2020
Actual Study Start Date October 30, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2019)
  • Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIMI [ Time Frame: Baseline ]
  • Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIMI [ Time Frame: Baseline ]
  • Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIMI [ Time Frame: Baseline ]
  • Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIMI [ Time Frame: Baseline ]
  • 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 ]
  • 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 ]
  • Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIMI [ Time Frame: Baseline ]
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 4, 2019)
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)
Original Secondary Outcome Measures
 (submitted: January 31, 2019)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
Official Title Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood
Sampling Method Non-Probability Sample
Study Population Patients receiving care at a participating study site
Condition
  • Pulmonary Invasive Mold Infections
  • Pulmonary Invasive Aspergillosis
Intervention Diagnostic Test: Non-Invasive Testing for PIMI
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
Study Groups/Cohorts Patients with possible PIMI
Intervention: Diagnostic Test: Non-Invasive Testing for PIMI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 31, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 120 Days to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: PFN Central Coordinator 919-668-4847 PFNClinical@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03827694
Other Study ID Numbers Pro00094558
R01AI139032 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators
  • Children's Hospital of Philadelphia
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: William Steinbach Duke University
Principal Investigator: Brian Fisher Children's Hospital of Philadelphia
PRS Account Duke University
Verification Date December 2020