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

Sponsor
PreDxion Bio, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04295278
Collaborator
(none)
25
Enrollment
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Mortality [28-day]

    28-day in hospital mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Weeks to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • PreDxion Bio, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PreDxion Bio, Inc.
ClinicalTrials.gov Identifier:
NCT04295278
Other Study ID Numbers:
  • PDXN-BP-001
First Posted:
Mar 4, 2020
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Multiple Organ Failure

Study Results

No Results Posted as of Sep 16, 2020