Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT02055105
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2014-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Molecular Fingerprinting in Pediatric Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035683', 'term': 'MicroRNAs'}], 'ancestors': [{'id': 'D016372', 'term': 'RNA, Antisense'}, {'id': 'D016375', 'term': 'Antisense Elements (Genetics)'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012313', 'term': 'RNA'}, {'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D058727', 'term': 'RNA, Small Untranslated'}, {'id': 'D022661', 'term': 'RNA, Untranslated'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2014-01-27', 'studyFirstSubmitQcDate': '2014-02-03', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of Mortality', 'timeFrame': 'Duration of hospital stay, an expected average of 3 weeks', 'description': 'Will compare PRISM 3 scores from baseline to hospital discharge.'}], 'secondaryOutcomes': [{'measure': 'Organ Failure', 'timeFrame': 'Duration of hospital stay, an expected average of 3 weeks', 'description': 'Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization.'}, {'measure': 'Organ Dysfunction', 'timeFrame': 'Duration of hospital stay, an expected average of 3 weeks', 'description': 'Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization'}, {'measure': 'Patient acuity', 'timeFrame': 'Duration of hospital stay, an expected average of 3 weeks', 'description': 'Will assess TISS-28 scores throughout hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Sepsis'], 'conditions': ['Systemic Inflammatory Response Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1 through 18 years\n* Patients admitted to the PICU with concerns for sepsis or those developing sepsis during their admission to the hospital.\n* 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.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients \\<1 year of age and greater than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT02055105', 'briefTitle': 'Modulation of Molecular Fingerprinting in Pediatric Sepsis', 'organization': {'class': 'OTHER', 'fullName': "Phoenix Children's Hospital"}, 'officialTitle': 'Modulation of Molecular Fingerprinting in Pediatric Sepsis', 'orgStudyIdInfo': {'id': 'PHNX-biosep-12159'}}, 'armsInterventionsModule': {'armGroups': [{'label': '10 Patients with sepsis or septic shock', 'description': '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.', 'interventionNames': ['Procedure: miRNA in Sepsis']}, {'label': '50 Healthy Patients', 'description': 'Healthy non-immunocompromised patients between 1-18 years old'}], 'interventions': [{'name': 'miRNA in Sepsis', 'type': 'PROCEDURE', 'description': 'miRNA in Sepsis', 'armGroupLabels': ['10 Patients with sepsis or septic shock']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Althaia Calla G Ignacio', 'role': 'CONTACT', 'email': 'aignacio@phoenixchildrens.com', 'phone': '8328007256'}, {'name': 'Aimee LaBell, BSN, MSN', 'role': 'CONTACT', 'email': 'alabell@phoenixchildrens.com', 'phone': '6029335307'}], 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85019', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amit Misra, MD', 'role': 'CONTACT', 'email': 'amisra@phoenixchildrens.com', 'phone': '6029331784'}], 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'centralContacts': [{'name': 'Frederick A Willyerd, MD', 'role': 'CONTACT', 'email': 'fwillyerd@phoenixchildrens.com', 'phone': '6029331784'}, {'name': 'Althaia Calla G Ignacio, BSN, MD', 'role': 'CONTACT', 'email': 'aignacio@phoenixchildrens.com', 'phone': '6029333795'}], 'overallOfficials': [{'name': 'Frederick A Willyerd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Phoenix Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Principal investigator is undecided if he plans on having a DTA or MTA.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Phoenix Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}