Ventilator Associated Pneumonia by Multi-Drug Resistant Organism
NCT ID: NCT05549427
Last Updated: 2022-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
319 participants
OBSERVATIONAL
2022-06-09
2022-08-17
Brief Summary
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Detailed Description
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Investigators 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.
The 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.
Aim of the Study :
The current study examines the distribution of MDR organisms in VAP and its incidence and outcome.
The primary outcome is to find the distribution of MDR bacteria in VAP-positive patients
The secondary outcomes
1. is to find the incidence of VAP in ICU patients.
2. to find outcomes for VAP patients.
3. to study the antibiotic sensitivity for VAP-causing organisms.
Investigators hope to formulate improvement strategies to minimize the incidence of MDR VAP, enhance ICU care, and reduce the incidence of VAP in ICU.
Methodology
Study Population: General Adult (\>13 years) ICU patients on ventilators at SQUH
Study Design and Methods:
Design: This is a single center retrospective cohort study.
Sample size: All ICU patients on ventilators fulfilling inclusion criteria during the study period starting from 1/04/2021 to 31/03/2022
Study Method:
After 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).
Demographic 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.
Justification of the current study:
In 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.
Data Management and Analyses:
Statistical 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.
To 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.
The analysis results will be used in a suitable form for publication.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Ventilation
Ventilation in ICU
Eligibility Criteria
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Inclusion Criteria
* Patient who got intubation and mechanical ventilation for more than 48 hours (for VAP0
* Positive MDR bacterial respiratory culture for defining MDR VAP
Exclusion Criteria
* Patient with tracheobronchitis
* Patients positive for fungal cultures
* Patients with pneumonia before intubation
* Non-MDR VAP
13 Years
ALL
No
Sponsors
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Sultan Qaboos University
OTHER
Responsible Party
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Dr Jyoti Burad
Principle investigator
Principal Investigators
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Jyoti Burad, MD, EDIC
Role: PRINCIPAL_INVESTIGATOR
Sultan Qaboos University Hospital
Locations
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Sultan Qaboos University Hospital
Muscat, , Oman
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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MREC#2783
Identifier Type: -
Identifier Source: org_study_id