Non-invasive diagnosis of lung infections caused by mold in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish a non-invasive diagnostic approach for detecting pulmonary invasive fungal infections (PIFI) in children who are at high risk. It will evaluate clinical outcomes associated with this diagnostic method, focusing on children with conditions such as hematopoietic stem cell transplantation or malignancies. The study will involve non-invasive testing methods to identify specific radiographic signs indicative of PIFI. By utilizing advanced imaging techniques, the study seeks to improve early detection and management of these serious infections.

Why it matters

Who can join: the full rules

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

Where it's running

• Arkansas Children's Research Institute
  Little Rock, Arkansas, United States Recruiting
• Rady Children's Hospital, UCSD
  La Jolla, California, United States Recruiting
• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• Lucile Packard Children's Hospital, Stanford University
  Palo Alto, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: William Steinbach — University of Arkansas
• Study coordinator: PFN Central Coordinator
• Email: PFNClinical@uams.edu
• Phone: 501-364-3057

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.