Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Recruiting

• Conditions: Pulmonary Invasive Fungal Infections; Pulmonary Invasive Aspergillosis

• Registration Number: NCT03827694
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Status Verified: 2023-07
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI	Baseline
Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI	Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a positive result among subjects determined to have PIFI	Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a negative result among subjects determined not to have PIFI	Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI	Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI	Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI	Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI	Baseline

Secondary Outcome Measures

Name	Time	Method
Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure	49 days	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)

Trial Locations

Locations (33)

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Arkansas Children's Research Institute; 🇺🇸 Little Rock, Arkansas, United States

Rady Children's Hospital, UCSD; 🇺🇸 La Jolla, California, United States

Lucile Packard Children's Hospital, Stanford University; 🇺🇸 Palo Alto, California, United States

University of California San Francisco, Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States

All Children's Research Institute; 🇺🇸 Saint Petersburg, Florida, United States

Emory University-Children's Healthcare of Atlanta (CHOA); 🇺🇸 Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

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