NCT03827694 Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
| NCT ID | NCT03827694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arkansas Children's Hospital Research Institute |
| Condition | Pulmonary Invasive Fungal Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2018-10-30 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2018-10-30 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
William Steinbach
PRINCIPAL INVESTIGATOR
University of Arkansas
Frequently Asked Questions
Who can join the NCT03827694 clinical trial?
This trial is open to participants of all sexes, aged 120 Days or older, up to 21 Years, studying Pulmonary Invasive Fungal Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03827694 currently recruiting?
Yes, NCT03827694 is actively recruiting participants. Contact the research team at PFNClinical@uams.edu for enrollment information.
Where is the NCT03827694 trial being conducted?
This trial is being conducted at Little Rock, United States, La Jolla, United States, Orange, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT03827694 clinical trial?
NCT03827694 is sponsored by Arkansas Children's Hospital Research Institute. The principal investigator is William Steinbach at University of Arkansas. The trial plans to enroll 400 participants.