Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT06246994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Mortality Among Ventilator Associated Pneumonia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate at 28 days.', 'timeFrame': '28 days', 'description': 'Evaluation of number of dead patients from vap wihin 28 days of infection and'}, {'measure': 'Percentage of risk factors of VAP mortality.', 'timeFrame': '28 days', 'description': 'Search for risk factors for mortality of vap wihin 28 days of infection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '32207816', 'type': 'RESULT', 'citation': 'Vincent JL, Sakr Y, Singer M, Martin-Loeches I, Machado FR, Marshall JC, Finfer S, Pelosi P, Brazzi L, Aditianingsih D, Timsit JF, Du B, Wittebole X, Maca J, Kannan S, Gorordo-Delsol LA, De Waele JJ, Mehta Y, Bonten MJM, Khanna AK, Kollef M, Human M, Angus DC; EPIC III Investigators. Prevalence and Outcomes of Infection Among Patients in Intensive Care Units in 2017. JAMA. 2020 Apr 21;323(15):1478-1487. doi: 10.1001/jama.2020.2717.'}, {'pmid': '25461659', 'type': 'RESULT', 'citation': 'Zhou XY, Ben SQ, Chen HL, Ni SS. A comparison of APACHE II and CPIS scores for the prediction of 30-day mortality in patients with ventilator-associated pneumonia. Int J Infect Dis. 2015 Jan;30:144-7. doi: 10.1016/j.ijid.2014.11.005. Epub 2014 Nov 12.'}, {'pmid': '33516213', 'type': 'RESULT', 'citation': 'Arayasukawat P, So-Ngern A, Reechaipichitkul W, Chumpangern W, Arunsurat I, Ratanawatkul P, Chuennok W. Microorganisms and clinical outcomes of early- and late-onset ventilator-associated pneumonia at Srinagarind Hospital, a tertiary center in Northeastern Thailand. BMC Pulm Med. 2021 Jan 30;21(1):47. doi: 10.1186/s12890-021-01415-8.'}, {'pmid': '32719205', 'type': 'RESULT', 'citation': 'John AO, Paul H, Vijayakumar S, Anandan S, Sudarsan T, Abraham OC, Balaji V. Mortality from acinetobacter infections as compared to other infections among critically ill patients in South India: A prospective cohort study. Indian J Med Microbiol. 2020 Jan-Mar;38(1):24-31. doi: 10.4103/ijmm.IJMM_19_492.'}, {'pmid': '16932234', 'type': 'RESULT', 'citation': 'Zimmerman JE, Kramer AA, McNair DS, Malila FM, Shaffer VL. Intensive care unit length of stay: Benchmarking based on Acute Physiology and Chronic Health Evaluation (APACHE) IV. Crit Care Med. 2006 Oct;34(10):2517-29. doi: 10.1097/01.CCM.0000240233.01711.D9.'}]}, 'descriptionModule': {'briefSummary': 'In this context, this study aims to explore the risk factors for mortality from VAP in respiratory ICU.', 'detailedDescription': 'Pneumonia is the most common infection treated within ICUs and carries significant mortality risk . Ventilator-associated pneumonia (VAP) is a specific form of nosocomial pneumonia occurring in patients greater than 48 hours after intubation and the initiation of mechanical ventilation .\n\nVAP is considered a leading cause of morbidity and mortality among intensive care unit infections. Despite various preventive measures, the incidence of VAP remains high .\n\nIn studies, VAP-related mortality is 14-70% . It is contemplated that there are independent risk factors, increasing VAP-related mortality .\n\nHowever, the question of which factors are associated with early or late mortality in patients with VAP diagnosis, remains unanswered. Early identification and understanding of the etiology of VAP in the ICU is essential to prevent mortality and morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll adult participants over 18 years old who had undergone mechanical ventilation for longer than 48 hours. Only the first episode of VAP for each patient will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:This study will enroll:\n\n1. adult participants over 18 years old who had undergone mechanical ventilation for longer than 48 hours.\n2. Only the first episode of VAP for each patient will be included.\n\nExclusion Criteria:\n\n1. Patients who are less than 18 years old.\n2. Pneumonia diagnosed before mechanical ventilation.'}, 'identificationModule': {'nctId': 'NCT06246994', 'briefTitle': 'Predictors of Mortality Among Ventilator Associated Pneumonia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Predictors of Mortality Among Ventilator Associated Pneumonia Patients', 'orgStudyIdInfo': {'id': 'Predictors of vap mortality'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa Kilany, Assisst- lecture', 'role': 'CONTACT', 'email': 'docmero1693@gmail.com', 'phone': '01064123545'}, {'name': 'Saher Mahmoud, lecture', 'role': 'CONTACT', 'email': 'farida62014@gmail.com', 'phone': '01002866364'}], 'overallOfficials': [{'name': 'Doaa Magdy, assisst -professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Marwa Hussien kilany', 'investigatorAffiliation': 'Assiut University'}}}}