Recruiting

Micro RNA Biomarkers

Sponsor:

Phoenix Children's Hospital

Code:

NCT02055105

Conditions

Systemic Inflammatory Response Syndrome

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Interventions

miRNA in Sepsis

Study Details

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

Study ID

NCT02055105

Start date

Mar, 2014

Status verified date

Oct, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

50 Healthy Patients

Healthy non-immunocompromised patients between 1-18 years old

Interventions

miRNA in Sepsis

miRNA in Sepsis

Primary outcome measure

  • Risk of Mortality [ Time Frame: Duration of hospital stay, an expected average of 3 weeks ]

Central Contacts and Locations

Central contacts

Frederick A Willyerd, MD

6029331784fwillyerd@phoenixchildrens.com

Althaia Calla G Ignacio, BSN, MD

6029333795aignacio@phoenixchildrens.com

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Althaia Calla G Ignacio

8328007256aignacio@phoenixchildrens.com

Aimee LaBell, BSN, MSN

6029335307alabell@phoenixchildrens.com

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85019

Contacts

Amit Misra, MD

6029331784amisra@phoenixchildrens.com

More Information

Sponsor

Phoenix Children's Hospital

Last update posted

Nov 12, 2025

Last verified

Oct, 2025

Keywords

  • Pediatric Sepsis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phoenix Children's Hospital on 2025-11-12.