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Modulation of Molecular Fingerprinting in Pediatric Sepsis

NCT ID: NCT02055105

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2027-10-31

Brief Summary

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The goal of this study is to demonstrate the sensitivity and specificity of detecting circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow expression and modulation of levels in response to therapy in comparison to current biomarkers.

Detailed Description

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This study will aid in the evaluation of determining the accuracy of these miRNAs in pediatric patients and help in establishing pilot data for additional studies in the future. The testing will include blood samples, urine samples and buccal swabs from patients who meet eligibility at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including updated Pediatric Risk of Mortality (PRISM III) scores and simplified Therapeutic Intervention Scoring System(TISS-28) scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry. Data will be recorded in a de-identified manner on a Microsoft Excel database on a secure institutional server by the institutional staff. Data will then be analyzed to determine correlation of biomarkers to morbidity and mortality for these patients.

Conditions

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Systemic Inflammatory Response Syndrome

Keywords

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Pediatric Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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10 Patients with sepsis or septic shock

Previously healthy, non-immunocompromised patients, between the ages of 1 and 18, who are being admitted to the PCH PICU for sepsis or septic shock, will be enrolled. Blood samples, urine samples and buccal swabs will be obtained from these patients at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including PRISM scores and TISS-28 scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry.

miRNA in Sepsis

Intervention Type PROCEDURE

miRNA in Sepsis

50 Healthy Patients

Healthy non-immunocompromised patients between 1-18 years old

No interventions assigned to this group

Interventions

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miRNA in Sepsis

miRNA in Sepsis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 1 through 18 years
* Patients admitted to the PICU with concerns for sepsis or those developing sepsis during their admission to the hospital.
* Patients must be enrolled int he study from arrival time tot he ED up to 24 hours from the time of initiation of antibiotic therapy for treatment of sepsis or septic shock.
* Signed informed consent.

Exclusion Criteria

* Patients \<1 year of age and greater than 18 years of age.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phoenix Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederick A Willyerd, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Children's Hospital

Locations

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Frederick A Willyerd, MD

Role: CONTACT

Phone: 6029331784

Email: [email protected]

Althaia Calla G Ignacio, BSN, MD

Role: CONTACT

Phone: 6029333795

Email: [email protected]

Facility Contacts

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Althaia Calla G Ignacio

Role: primary

Aimee LaBell, BSN, MSN

Role: backup

Amit Misra, MD

Role: primary

Other Identifiers

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PHNX-biosep-12159

Identifier Type: -

Identifier Source: org_study_id