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

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Observational Arkansas Children's Hospital Research Institute · NCT03827694

This study is testing a new, non-invasive way to find lung infections caused by mold in children who are at high risk due to serious health conditions.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages120 Days to 21 Years
SexAll
SponsorArkansas Children's Hospital Research Institute Academic / other
Locations33 sites (Little Rock, Arkansas and 32 other locations)
Trial IDNCT03827694 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged over 120 days and under 22 years who have conditions associated with a high incidence of invasive fungal infections.

Not a fit: Patients who do not have the specified high-risk conditions or recent radiographic evidence of pulmonary lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of pulmonary fungal infections in children, potentially improving treatment outcomes.

How similar studies have performed: Other studies have shown promise in using non-invasive methods for diagnosing pulmonary infections, but this specific approach for pediatric populations is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Little Rock, Arkansas and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Invasive Fungal InfectionsPulmonary Invasive Aspergillosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.