Clinical trial NCT05549427: Ventilator Associated Pneumonia by Multi-Drug Resistant Organism
Official title: A Retrospective Cohort Study on Ventilator Associated Pneumonia Caused by Multi-Drug Resistance Organism in SQUH ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Associated Pneumonia
Multi-antibiotic Resistance
Keywords: Ventilator Associated Pneumonia
Multi drug resistance
antibiotics
length of stay
mortality
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 319
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distribution of Multi-Drug Resistant (MDR) bacteria in VAP positive patients
timeFrame: upto 90 days
Secondary outcomes:
measure: Incidence of MDR-VAP in ICU patients
timeFrame: upto 90 days
measure: Outcome of MDR-VAP patients
timeFrame: upto 90 days
measure: Antibiotic sensitivity for MDR-VAP causing organism
timeFrame: upto 90 days
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Sultan Qaboos University Hospital
Study officials:
affiliation: Sultan Qaboos University Hospital
name: Jyoti Burad, MD, EDIC
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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.