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Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

ConditionsPulmonary Invasive Fungal InfectionsPulmonary Invasive Aspergillosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age120-21
SponsorArkansas Children's Hospital Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw

Previous inclusion in this study

Trial population

Patients receiving care at a participating study site

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Invasive Testing for PIFI

    Diagnostic test

    galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Patients with possible PIFI1 intervention

Trial outcomes

Primary outcomes

1

Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI

Time frame
Baseline
2

Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI

Time frame
Baseline
3

Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI

Time frame
Baseline
4

Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI

Time frame
Baseline

Secondary outcomes

1

Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure

Outcome score inclusive of outcomes and adverse events. Comprehensive clinical outcome score from most to least desirable are score of 1 (survival, improvement in pulmonary nodules, no adverse events related to anti-fungal therapy or invasive diagnostic intervention) to score of 7 (death)

Time frame
49 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arkansas Children's Hospital Research Institute

Lead sponsor

Children's Hospital of Philadelphia

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov
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