Ventilator Associated Pneumonia by Multi-Drug Resistant Organism (VAP-MDR)

A Retrospective Cohort Study on Ventilator Associated Pneumonia Caused by Multi-Drug Resistance Organism in SQUH ICU

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia; Multi-antibiotic Resistance
• Intervention / Treatment: Other: Ventilation

Detailed Description

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%.

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.

• Study Type: Observational
• Enrollment (Actual): 319

Contacts and Locations

Study Locations

• Oman
  • Muscat, Oman, 123
    • Sultan Qaboos University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Adult patients (more than 13 years old) admitted to ICU (covid/non-covid) (for VAP rate)
• 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 for MDR VAP:

• Non-ventilated patients.
• Patient with tracheobronchitis
• Patients positive for fungal cultures
• Patients with pneumonia before intubation
• Non-MDR VAP

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Multi-Drug Resistant (MDR) bacteria in VAP positive patients	Frequency and classes of MDR organisms isolated from respiratory specimens of ventilated patients for more than 48 hours	upto 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MDR-VAP in ICU patients	Incidence of VAP with MDR organisms during the study period.	upto 90 days
Outcome of MDR-VAP patients	Outcomes like: Survival versus Mortality and Extubation versus Tracheostomy	upto 90 days
Antibiotic sensitivity for MDR-VAP causing organism	The antibiotic sensitivity of MDR-VAP organisms	upto 90 days

Collaborators and Investigators

• Sponsor: Sultan Qaboos University
• Investigators: Principal Investigator: Jyoti Burad, MD, EDIC, Sultan Qaboos University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: September 17, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: mortality; Ventilator Associated Pneumonia; antibiotics; length of stay; Multi drug resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: MREC#2783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan 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
• IPD Sharing Time Frame: The data will be available after three months of publication of the present study indefinitely.
• IPD Sharing Access Criteria: Those who require data for research, will be provided with this dataset.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No