Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-30 @ 12:47 PM
Study NCT ID:
NCT01652404
Status:
UNKNOWN
Last Update Posted:
2012-07-30
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-27', 'studyFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average antibiotics duration', 'timeFrame': '28 days', 'description': 'Efficacy endpoint'}, {'measure': '28-day mortality rate', 'timeFrame': '28 days', 'description': 'Safety endpoint'}], 'secondaryOutcomes': [{'measure': 'Proportion of antibiotics use in both arms', 'timeFrame': '28 days', 'description': 'Efficacy endpoint'}, {'measure': 'Length of ICU stay', 'timeFrame': '90 days', 'description': 'Efficacy endpoint'}, {'measure': 'Recurrence of fever within 72 hours of antibiotics discontinuation', 'timeFrame': '28 days', 'description': 'Safety endpoint'}, {'measure': 'SOFA score (Sequential Organ Failure Assessment score)', 'timeFrame': '28 days', 'description': 'Safety endpoint'}, {'measure': 'Reinfection rate between 72-hours and 28 days post antibiotics discontinuation', 'timeFrame': '28 days', 'description': 'Safety endpoint'}, {'measure': '90-day all-cause mortality', 'timeFrame': '90 days', 'description': 'Safety endpoint'}, {'measure': '90-day readmission rate', 'timeFrame': '90 days', 'description': 'Safety endpoint'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICU', 'sepsis', 'antibiotic therapy', 'procalcitonin'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '12535494', 'type': 'BACKGROUND', 'citation': 'Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966.'}, {'pmid': '21034941', 'type': 'BACKGROUND', 'citation': 'Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to give conclusive evidence on whether serial PCT (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).', 'detailedDescription': 'In this study, the investigators aimed to design a multi-center trial addressing aforementioned flaws. The investigators will set stricter inclusion criteria, collect complete data on relapse or secondary infection, and include sufficient number of patients to show non-inferiority to conventional therapy by a delta margin of 10% \\[11\\]. The investigators aimed to give conclusive evidence on whether serial PCT measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients with laboratory- or image-confirmed severe infection at admission or during stay in pediatric ICU will be eligible for inclusion.\n\n\\* Definition of laboratory- or image-confirmed severe infection:\n\n* Two or more of four signs of inflammation:\n\n * Temperature \\>38.3℃ or \\<36℃\n * Heart rate \\> 90 beats/min\n * Respiratory rate \\>20 breaths/min or PaCO2 (Arterial pressure of carbon dioxide) \\< 32 mmHg\n * WBC (White Blood Cell count) \\> 12,000 cells/mm3, \\<4000 cells/mm3, or \\>5% band-form WBC\n* Initial Procalcitonin \\> 0.5 ng/mL\n* Presence of either laboratory or image evidence of infection\n* Laboratory evidence: Sign of inflammation in urine, CSF (Cerebrospinal Fluid), ascites, pleural effusion or local abscess\n* Image evidence: Compatible findings on Chest X ray, ultrasound, CT (Computed Tomography), MR image (Magnetic Resonance Image)\n\nExclusion Criteria:\n\n* Age greater than 15 years or less than 1 month\n* Known pregnancy\n* Expected ICU stay less than 3 days\n* Neutropenia: ANC (Absolute Neutrophil Count) \\<500/mm3\n* Specific infections for which long-term antibiotic treatment is strongly recommended:\n\n * Lobar pneumonia or empyema\n * Bacterial meningitis\n * Osteomyelitis\n * Infective endocarditis\n * Local abscess\n * Mediastinitin'}, 'identificationModule': {'nctId': 'NCT01652404', 'acronym': 'ProShort-Ped', 'briefTitle': 'PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': "Hunan Children's Hospital"}, 'officialTitle': 'PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial', 'orgStudyIdInfo': {'id': 'HN01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Procalcitonin-guided treatment', 'description': 'The duration of antibiotics will be determined by the procalcitonin levels.', 'interventionNames': ['Behavioral: Procalcitonin-guided treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'The duration of antibiotics will be determined by the treating physician.', 'interventionNames': ['Behavioral: Conventional treatment']}], 'interventions': [{'name': 'Procalcitonin-guided treatment', 'type': 'BEHAVIORAL', 'description': 'The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.', 'armGroupLabels': ['Procalcitonin-guided treatment']}, {'name': 'Conventional treatment', 'type': 'BEHAVIORAL', 'description': 'The antibiotics duration will be determined by treating physician.', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi-Min Zhu, BSc', 'role': 'CONTACT', 'email': 'csvzhuyimin@163.com', 'phone': '073185386850'}, {'name': 'Yi-Min Zhu, BSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hunan Children's Hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Chien-Chang Lee, MD, MSc', 'role': 'CONTACT', 'email': 'cclee100@gmail.com', 'phone': '886972651951'}, {'name': 'Yi-Min Zhu, BSc', 'role': 'CONTACT', 'email': 'csvzhuyimin@163.com', 'phone': '073185356850'}], 'overallOfficials': [{'name': 'Chien-Chang Lee, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Yi-Min Zhu, BSc', 'role': 'STUDY_CHAIR', 'affiliation': "Hunan Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hunan Children's Hospital", 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Taiwan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}