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NCT04295278 Clinical Trial

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

Multiple Organ Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04295278
Other study ID # PDXN-BP-001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2021
Est. completion date December 2022

Study information
Verified date September 2020
Source PreDxion Bio, Inc.
Contact Clinical Trial Information
Phone (650) 877-2309?
Email clinicaltrials@predxionbio.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 38 Weeks to 21 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
PreDxion Bio, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality 28-day in hospital mortality 28-day
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