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

NCT04295278 | Unknown FDA Device

• 1 other identifier: PDXN-BP-001
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Organ Failure

Outcome Measures

Primary Outcomes (1)

• Mortality

  28-day in hospital mortality

  28-day

Study Arms (1)

Systemic inflammatory response syndrome

Systemic inflammatory response syndrome in patients in the pediatric intensive care unit.

Diagnostic Test: MicroKine Dx system

Interventions

MicroKine Dx system DIAGNOSTIC_TEST

Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays.

Systemic inflammatory response syndrome

Eligibility Criteria

• Age: 38 Weeks - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• PreDxion Bio, Inc.: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Information

  PreDxion Bio, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Trial Information

CONTACT

(650) 877-2309‬; clinicaltrials@predxionbio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09