Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Keywords

Pulmonary Invasive Mold Infections Pulmonary Invasive Aspergillosis Infection Communicable Diseases Aspergillosis Invasive Pulmonary Aspergillosis Non-Invasive Testing for PIMI

Eligibility

You can join if…

Open to people ages up to 21 years

  • 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

You CAN'T join if...

  • Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
  • Previous inclusion in this study

Locations

  • University of California San Francisco, Benioff Children's Hospital accepting new patients
    San Francisco California 94143 United States
  • Lucile Packard Children's Hospital, Stanford University accepting new patients
    Palo Alto California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT03827694
Study Type
Observational
Last Updated