Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05549427
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2022-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ventilator Associated Pneumonia by Multi-Drug Resistant Organism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014691', 'term': 'Ventilation'}], 'ancestors': [{'id': 'D004780', 'term': 'Environment, Controlled'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-09-17', 'studyFirstSubmitQcDate': '2022-09-17', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of Multi-Drug Resistant (MDR) bacteria in VAP positive patients', 'timeFrame': 'upto 90 days', 'description': 'Frequency and classes of MDR organisms isolated from respiratory specimens of ventilated patients for more than 48 hours'}], 'secondaryOutcomes': [{'measure': 'Incidence of MDR-VAP in ICU patients', 'timeFrame': 'upto 90 days', 'description': 'Incidence of VAP with MDR organisms during the study period.'}, {'measure': 'Outcome of MDR-VAP patients', 'timeFrame': 'upto 90 days', 'description': 'Outcomes like: Survival versus Mortality and Extubation versus Tracheostomy'}, {'measure': 'Antibiotic sensitivity for MDR-VAP causing organism', 'timeFrame': 'upto 90 days', 'description': 'The antibiotic sensitivity of MDR-VAP organisms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventilator Associated Pneumonia', 'Multi drug resistance', 'antibiotics', 'length of stay', 'mortality'], 'conditions': ['Ventilator Associated Pneumonia', 'Multi-antibiotic Resistance']}, 'referencesModule': {'references': [{'pmid': '28189513', 'type': 'BACKGROUND', 'citation': 'Djordjevic ZM, Folic MM, Jankovic SM. Distribution and antibiotic susceptibility of pathogens isolated from adults with hospital-acquired and ventilator-associated pneumonia in intensive care unit. J Infect Public Health. 2017 Nov-Dec;10(6):740-744. doi: 10.1016/j.jiph.2016.11.016. Epub 2017 Feb 8.'}, {'pmid': '28250674', 'type': 'BACKGROUND', 'citation': 'Patil HV, Patil VC. Incidence, bacteriology, and clinical outcome of ventilator-associated pneumonia at tertiary care hospital. J Nat Sci Biol Med. 2017 Jan-Jun;8(1):46-55. doi: 10.4103/0976-9668.198360.'}, {'pmid': '28288860', 'type': 'BACKGROUND', 'citation': 'Gupta R, Malik A, Rizvi M, Ahmed M, Singh A. Epidemiology of multidrug-resistant Gram-negative pathogens isolated from ventilator-associated pneumonia in ICU patients. J Glob Antimicrob Resist. 2017 Jun;9:47-50. doi: 10.1016/j.jgar.2016.12.016. Epub 2017 Apr 10.'}, {'pmid': '33857475', 'type': 'BACKGROUND', 'citation': 'Grasselli G, Scaravilli V, Mangioni D, Scudeller L, Alagna L, Bartoletti M, Bellani G, Biagioni E, Bonfanti P, Bottino N, Coloretti I, Cutuli SL, De Pascale G, Ferlicca D, Fior G, Forastieri A, Franzetti M, Greco M, Guzzardella A, Linguadoca S, Meschiari M, Messina A, Monti G, Morelli P, Muscatello A, Redaelli S, Stefanini F, Tonetti T, Antonelli M, Cecconi M, Foti G, Fumagalli R, Girardis M, Ranieri M, Viale P, Raviglione M, Pesenti A, Gori A, Bandera A. Hospital-Acquired Infections in Critically Ill Patients With COVID-19. Chest. 2021 Aug;160(2):454-465. doi: 10.1016/j.chest.2021.04.002. Epub 2021 Apr 20.'}, {'pmid': '34045810', 'type': 'BACKGROUND', 'citation': 'Sangale A, Vivek B, Kelkar R, Biswas S. Microbiology of Ventilator-associated Pneumonia in a Tertiary Care Cancer Hospital. Indian J Crit Care Med. 2021 Apr;25(4):421-428. doi: 10.5005/jp-journals-10071-23790.'}, {'pmid': '32157357', 'type': 'BACKGROUND', 'citation': 'Papazian L, Klompas M, Luyt CE. Ventilator-associated pneumonia in adults: a narrative review. Intensive Care Med. 2020 May;46(5):888-906. doi: 10.1007/s00134-020-05980-0. Epub 2020 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'Ventilator-associated pneumonia (VAP) is an infection of the pulmonary parenchyma in patients exposed to invasive mechanical ventilation for at least 48 h and is part of ICU-acquired pneumonia. VAP is one of the most frequent ICU-acquired infections. Reported incidences vary widely from 5 to 40%, depending on the setting and diagnostic criteria. The estimated attributable mortality of VAP is around 10%. Investigators will focus this study on the current understanding of the epidemiology and treatment of VAP caused by multi-drug resistant (MDR) organisms. The MDR organisms are significant threats to the prognosis of the ICU patient. They are challenging to treat because of a limited number of newer antibiotics available for treatment. Understanding their distribution and sensitivity pattern may provide clues on how to deal with this significant problem. The current study examines the distribution of MDR organisms in VAP and its incidence and outcome. Investigators will also study the sensitivity pattern of these MDR organisms and how it affects the patient outcome. All patients admitted to adult ICU will be scanned, positive respiratory cultures will be noted, and those with VAP will be studied in detail. Patient data will be collected using the hospital information system.', 'detailedDescription': "Introduction Ventilator-associated pneumonia (VAP) is defined as an infection of the pulmonary parenchyma in patients exposed to invasive mechanical ventilation for at least 48 h and is part of ICU-acquired pneumonia. VAP is one of the most frequent ICU-acquired infections. Reported incidences vary widely from 5 to 40%, depending on the setting and diagnostic criteria. VAP is associated with prolonged duration of mechanical ventilation and ICU stay. The estimated attributable mortality of VAP is around 10%.\n\nInvestigators will focus this study on the current understanding of the epidemiology and treatment of VAP caused by multi-drug resistant (MDR). Other conditions such as ventilator-associated tracheobronchitis are not detailed.\n\nThe MDR organisms are significant threats to the prognosis of the ICU patient. These organisms are usually acquired in hospitals due to multiple factors like antibiotic use, immunosuppression, prolonged stay in the hospital, etc. They are challenging to treat because of a limited number of newer antibiotics available for treatment. Understanding their distribution and sensitivity pattern may provide clues on how to deal with this significant problem.\n\nAim of the Study :\n\nThe current study examines the distribution of MDR organisms in VAP and its incidence and outcome.\n\nThe primary outcome is to find the distribution of MDR bacteria in VAP-positive patients\n\nThe secondary outcomes\n\n1. is to find the incidence of VAP in ICU patients.\n2. to find outcomes for VAP patients.\n3. to study the antibiotic sensitivity for VAP-causing organisms.\n\nInvestigators hope to formulate improvement strategies to minimize the incidence of MDR VAP, enhance ICU care, and reduce the incidence of VAP in ICU.\n\nMethodology\n\nStudy Population: General Adult (\\>13 years) ICU patients on ventilators at SQUH\n\nStudy Design and Methods:\n\nDesign: This is a single center retrospective cohort study.\n\nSample size: All ICU patients on ventilators fulfilling inclusion criteria during the study period starting from 1/04/2021 to 31/03/2022\n\nStudy Method:\n\nAfter obtaining ethical approval, all the patients admitted to ICU during the study period will be scanned for eligibility criteria. Patients with VAP will be studied using electronic patient records (EPR).\n\nDemographic Data: Age and gender of the patients will be recorded. Diagnosis Data: Positive respiratory culture for MDR, Treatment Data: Empirical antibiotics and treatment of VAP Microbiology data: sensitivity and culture reports Other data: VAP days, ventilator days, and outcome: extubation, tracheostomy, survival, death.\n\nJustification of the current study:\n\nIn this study, Investigators intend to determine the incidence of VAP due to MDR organism and associated outcomes. This will help in understanding VAP due to MDR organisms.\n\nData Management and Analyses:\n\nStatistical analysis: Database for the study sample shall be created in SPSS-23. Categorized variables shall be displayed as percentages using frequency tables and pie charts or bar charts, and continuous variables shall be shown as Mean ± SD and error bar charts.\n\nTo test the significance of association between categorized variables, Chi-square or Fisher's exact test, as appropriate, shall be used. To test the significance of the difference between the means of two groups, an independent sample t-test will be applied if the distribution pattern of the variable under study is normal, and in case of non-normal behavior of the data; the Mann-Whitney test shall be applied. Similarly, for comparing means of 3 or more groups, ANOVA or Kruskal-Wallis test shall be used depending on the distribution pattern of the study variable. A P-value of .05 or less shall be taken as significant.\n\nThe analysis results will be used in a suitable form for publication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (\\>13 years) admitted to ICU on a ventilator at a tertiary level center were scanned. Those who developed VAP with MDR organism (after 48 hours of ventilation and with new cultures after the initial negative culture) were labeled as MDR VAP cases. The remaining ventilated patients were considered to calculate VAP rate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (more than 13 years old) admitted to ICU (covid/non-covid) (for VAP rate)\n* Patient who got intubation and mechanical ventilation for more than 48 hours (for VAP0\n* Positive MDR bacterial respiratory culture for defining MDR VAP\n\nExclusion Criteria for MDR VAP:\n\n* Non-ventilated patients.\n* Patient with tracheobronchitis\n* Patients positive for fungal cultures\n* Patients with pneumonia before intubation\n* Non-MDR VAP'}, 'identificationModule': {'nctId': 'NCT05549427', 'acronym': 'VAP-MDR', 'briefTitle': 'Ventilator Associated Pneumonia by Multi-Drug Resistant Organism', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Qaboos University'}, 'officialTitle': 'A Retrospective Cohort Study on Ventilator Associated Pneumonia Caused by Multi-Drug Resistance Organism in SQUH ICU', 'orgStudyIdInfo': {'id': 'MREC#2783'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ventilation', 'type': 'OTHER', 'description': 'Ventilation in ICU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '123', 'city': 'Muscat', 'country': 'Oman', 'facility': 'Sultan Qaboos University Hospital', 'geoPoint': {'lat': 23.58413, 'lon': 58.40778}}], 'overallOfficials': [{'name': 'Jyoti Burad, MD, EDIC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sultan Qaboos University Hospital'}]}, 'ipdSharingStatementModule': {'url': 'https://data.mendeley.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The data will be available after three months of publication of the present study indefinitely.', 'ipdSharing': 'YES', 'description': 'The data will be shared with those who ask for it by email to the principal investigator for the research. The patient data and the statistical plan will be shared', 'accessCriteria': 'Those who require data for research, will be provided with this dataset.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Qaboos University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Dr Jyoti Burad', 'investigatorAffiliation': 'Sultan Qaboos University'}}}}