Tracking microRNA fingerprints in children with sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect blood, urine, and buccal swab samples from pediatric patients with suspected sepsis at five time points to measure circulating microRNA levels and compare them to current biomarkers. Enrolled patients will receive standard clinical care, including antimicrobials and organ support as needed, while clinical data are recorded to calculate severity scores such as PRISM III and TISS-28. Samples will be stored at -80°C and analyzed to determine sensitivity, specificity, and correlations between microRNA expression, treatment response, and outcomes. All patient data will be de-identified and entered into a secure database for analysis to generate pilot data for future studies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting

Study contacts

• Principal investigator: Frederick A Willyerd, MD — Phoenix Children's Hospital
• Study coordinator: Frederick A Willyerd, MD
• Email: fwillyerd@phoenixchildrens.com
• Phone: 6029331784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.