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NCT Number: NCT02055105

Modulation of Molecular Fingerprinting in Pediatric Sepsis

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.

Recruiting

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

miRNA in Sepsis

Procedure

miRNA in Sepsis

Primary outcomes

  1. Risk of Mortality

    Time frame: Duration of hospital stay, an expected average of 3 weeks

    Will compare PRISM 3 scores from baseline to hospital discharge.

Secondary outcomes

  1. Organ Failure

    Time frame: Duration of hospital stay, an expected average of 3 weeks

    Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization.

  2. Organ Dysfunction

    Time frame: Duration of hospital stay, an expected average of 3 weeks

    Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization

  3. Patient acuity

    Time frame: Duration of hospital stay, an expected average of 3 weeks

    Will assess TISS-28 scores throughout hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

Althaia Calla G Ignacio, BSN, MD

CONTACT

[email protected]

6029333795

Frederick A Willyerd, MD

CONTACT

[email protected]

6029331784

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2014
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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