Ventilator Associated Pneumonia by Multi-Drug Resistant Organism

Ventilator Associated Pneumonia Clinical Trial

— VAP-MDR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549427
• Other study ID #: MREC#2783
• Status: Completed
• Start date: June 9, 2022
• Est. completion date: August 17, 2022

Study information

• Verified date: September 2022
• Source: Sultan Qaboos University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multi-antibiotic Resistance
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Other:
• Ventilation
Ventilation in ICU

Locations

Country	Name	City	State
Oman	Sultan Qaboos University Hospital	Muscat

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Qaboos University

Country where clinical trial is conducted

Oman, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

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