Multiple Organ FailureNCT04295278
Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.
An observational study of Multiple Organ Failure, run by PreDxion Bio, Inc..
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. Read more about this study
- Who is it for?
- Ages 38 weeks to 21 years
- Conditions the study is for
- Multiple Organ Failure
- What is being tested?
- MicroKine Dx system
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 weeks to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Anticipated pediatric intensive care unit admission <24 hours
- Primary immunodeficiency
- Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Organ Failure
- Being tested
- MicroKine Dx system
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroKine Dx systemDiagnostic test
Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays.
| Study group | Role | What they receive |
|---|---|---|
| Systemic inflammatory response syndrome | Systemic inflammatory response syndrome in patients in the pediatric intensive care unit. Receives: Diagnostic Test: MicroKine Dx system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
28-day in hospital mortality
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study startJan 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PreDxion Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Information, Study director, PreDxion Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295278
- Sponsor's protocol ID
- PDXN-BP-001
- Status last verified
- Sep 2020
- First submitted
- 2 Mar 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04295278
- Acronym / sponsor ID
- PDXN-BP-001
- Conditions
- Multiple Organ Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- PreDxion Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic inflammatory response syndrome | – | Diagnostic Test: MicroKine Dx systemSystemic inflammatory response syndrome in patients in the pediatric intensive care unit. |
Who may qualify
- Ages
- 38 weeks to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Anticipated pediatric intensive care unit admission <24 hours
- Primary immunodeficiency
- Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroKine Dx systemBiomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays. | Diagnostic test | Systemic inflammatory response syndrome |
Primary outcome
Mortality
Time frame: 28-day
28-day in hospital mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Information study director
PreDxion Bio, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Organ Failure, run by PreDxion Bio, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information ((650) 877-2309, clinicaltrials@predxionbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.