Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Conditions

• Pulmonary Invasive Aspergillosis
• Pulmonary Invasive Fungal Infections

Eligibility Criteria

Sex

ALL

Age

120 Days - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Non-Invasive Testing for PIFI — DIAGNOSTIC_TEST
  galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq

Study Details

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

Key Dates

Start date

Oct 30, 2018

Status verified

Sep 2024

Primary completion

Dec 31, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

400 participants (estimated)

Arms

• Arm: Patients with possible PIFI

Primary Outcome Measure

Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]

Central Contacts

• PFN Central Coordinator
  501-364-3057
  [email protected]

Locations (32)

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