Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.

An Observational Phase 0 Study to Assess the Performance and Real-world Feasibility of Implementing the MicroKine Dx Biomarker-based Risk Stratification of Critically-ill Pediatric Patients

This study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

Study Overview

• Status: Unknown
• Conditions: Multiple Organ Failure
• Intervention / Treatment: Diagnostic test: MicroKine Dx system

Detailed Description

This study will enroll approximately 25 pediatric patients to assess the predictive performance of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

All enrolled patients will undergo a series of blood collection procedures during their admission to the pediatric intensive care unit. The levels of inflammatory cytokines, chemokines, and effectors will be assessed and used in multi-biomarker based prognostic and predictive algorithms to determine patients at risk of in-hospital mortality.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric critically-ill patients 38-weeks gestation to 21 years of age admitted to a pediatric intensive care unit within the last 24-hours, with >1 indwelling central catheter, and meeting ≥2 age-adapted SIRS criteria.

Description

Key Inclusion Criteria:

1. Age 38 weeks gestation to 21 years of age
2. Admitted to the PICU within the prior 24 hours
3. Indwelling catheters for obtaining blood
4. Meet ≥2 age-adapted SIRS criteria

Key Exclusion Criteria:

1. Anticipated pediatric intensive care unit admission <24 hours
2. Primary immunodeficiency
3. Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Systemic inflammatory response syndrome; Systemic inflammatory response syndrome in patients in the pediatric intensive care unit.	Diagnostic test: MicroKine Dx system; Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	28-day in hospital mortality	28-day

Collaborators and Investigators

• Sponsor: PreDxion Bio, Inc.
• Investigators: Study Director: Clinical Trial Information, PreDxion Bio, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (ACTUAL): March 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Multiple Organ Failure
• Other Study ID Numbers: PDXN-BP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No