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Recruiting NCT03827694

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

— Observational Pulmonary Invasive Fungal Infections Pulmonary Invasive Aspergillosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Invasive Testing for PIFI.
Who it may be relevant to
Registry conditions: Pulmonary Invasive Fungal Infections, Pulmonary Invasive Aspergillosis. Basic parameters: 120 Days — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI [Time frame: Baseline]
  • Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI [Time frame: Baseline]
  • Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI [Time frame: 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]
  • 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]
  • 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]
  • Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI [Time frame: 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]
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]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 32 centers
  • Arkansas Children's Research Institute — Little Rock
  • Rady Children's Hospital, UCSD — La Jolla
  • Children's Hospital of Orange County — Orange
  • Lucile Packard Children's Hospital, Stanford University — Palo Alto
  • University of California San Francisco, Benioff Children's Hospital — San Francisco
  • Yale University — New Haven
  • Children's National Hospital — Washington D.C.
  • All Children's Research Institute — St. Petersburg
  • … and 24 more centers
Canada · 1 center
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT03827694 · Pro00094558 · R01AI139032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗