Modulation of Molecular Fingerprinting in Pediatric Sepsis

NCT02055105 | Recruiting

• 1 other identifier: PHNX-biosep-12159
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

Pediatric Sepsis

Outcome Measures

Primary Outcomes (1)

• Risk of Mortality

  Will compare PRISM 3 scores from baseline to hospital discharge.

  Duration of hospital stay, an expected average of 3 weeks

Secondary Outcomes (3)

• Organ Failure

  Duration of hospital stay, an expected average of 3 weeks

• Organ Dysfunction

  Duration of hospital stay, an expected average of 3 weeks

• Patient acuity

  Duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

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.

Procedure: miRNA in Sepsis

50 Healthy Patients

Healthy non-immunocompromised patients between 1-18 years old

Interventions

miRNA in Sepsis PROCEDURE

miRNA in Sepsis

10 Patients with sepsis or septic shock

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 1-18 who are Immune-competent (no previous chronic medical conditions) patients being admitted to the PICU at PCH with concerns for sepsis or those developing sepsis during their admission to the hospital who require care in the PICU.

You may qualify if:

• 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.

You may not qualify if:

• Patients \<1 year of age and greater than 18 years of age.

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (2)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, 85019, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

MicroRNAs

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

RNA, Antisense; Antisense Elements (Genetics); Nucleic Acids, Nucleotides, and Nucleosides; RNA; Nucleic Acids; RNA, Small Untranslated; RNA, Untranslated

Study Officials

• Frederick A Willyerd, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederick A Willyerd, MD

CONTACT

6029331784; fwillyerd@phoenixchildrens.com

Althaia Calla G Ignacio, BSN, MD

CONTACT

6029333795; aignacio@phoenixchildrens.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 4, 2014
• Study Start: March 1, 2014
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-10

Locations

US (2)