Ventilator Associated Pneumonia by Multi-Drug Resistant Organism

NCT05549427 | Completed

• 1 other identifier: MREC#2783
• Study Type: observational
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Multi-antibiotic Resistance

Keywords

Ventilator Associated Pneumonia; Multi drug resistance; antibiotics; length of stay; mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of MDR-VAP in ICU patients

  upto 90 days

• Outcome of MDR-VAP patients

  upto 90 days

• Antibiotic sensitivity for MDR-VAP causing organism

  upto 90 days

Interventions

Ventilation OTHER

Ventilation in ICU

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, 123, Oman

Location

Related 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.

  PMID: 28189513 BACKGROUND

• 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: 28250674 BACKGROUND

• 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: 28288860 BACKGROUND

• 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: 33857475 BACKGROUND

• 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: 34045810 BACKGROUND

• 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.

  PMID: 32157357 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Jyoti Burad, MD, EDIC

  Sultan Qaboos University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 22, 2022
• Study Start: June 9, 2022
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after three months of publication of the present study indefinitely.
• Access Criteria: Those who require data for research, will be provided with this dataset.

Locations

OM (1)