Tracking microRNA fingerprints in children with sepsis
Modulation of Molecular Fingerprinting in Pediatric Sepsis
This project will test whether small circulating microRNA markers can be detected in children with sepsis and whether their levels change with treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Phoenix Children's Hospital Academic / other |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT02055105 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 1 through 18 years admitted to the pediatric intensive care unit with suspected sepsis or who develop sepsis during admission and enrolled within 24 hours of starting antibiotics are eligible.
Not a fit: Infants under 1 year, adults over 18, patients not admitted to the PICU, or those enrolled more than 24 hours after antibiotic initiation are not eligible and would not benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could lead to better biomarkers that help detect sepsis earlier or monitor treatment response in children.
How similar studies have performed: Previous adult and some pediatric studies have reported promising correlations between specific microRNAs and sepsis severity, but clinical utility as diagnostic or treatment-monitoring tools remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.