Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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).

Keywords

Pulmonary Invasive Fungal Infections, Pulmonary Invasive Aspergillosis, Infections, Communicable Diseases, Mycoses, Aspergillosis, Invasive Fungal Infections, Invasive Pulmonary Aspergillosis, Non-Invasive Testing for PIFI

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 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

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

  • Rady Children's Hospital, UCSD accepting new patients
    La Jolla California 92093 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
Arkansas Children's Hospital Research Institute
ID
NCT03827694
Study Type
Observational
Participants
Expecting 400 study participants
Last Updated