Ventilator Associated PneumoniaVAP-MDRNCT05549427
Ventilator Associated Pneumonia by Multi-Drug Resistant Organism
An observational study of Ventilator Associated Pneumonia and Multi-antibiotic Resistance, run by Sultan Qaboos University at 1 site in Oman.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Multi-antibiotic Resistance
- What is being tested?
- Ventilation
- How many people
- 319 participants
- Where
- 1 siteOman
- Study dates
- 9 Jun 2022to 17 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Non-ventilated patients.
- Patient with tracheobronchitis
- Patients positive for fungal cultures
- Patients with pneumonia before intubation
- Non-MDR VAP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- is to find the incidence of VAP in ICU patients.
- to find outcomes for VAP patients.
- 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.
- Being tested
- Ventilation
- Keywords
- Ventilator Associated Pneumonia, Multi drug resistance, antibiotics, length of stay, mortality
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilationOther
Ventilation in ICU
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: upto 90 days
Secondary outcomes (3)
Incidence of MDR-VAP in ICU patients
Incidence of VAP with MDR organisms during the study period.
Measured: upto 90 days
Outcome of MDR-VAP patients
Outcomes like: Survival versus Mortality and Extubation versus Tracheostomy
Measured: upto 90 days
Antibiotic sensitivity for MDR-VAP causing organism
The antibiotic sensitivity of MDR-VAP organisms
Measured: upto 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start9 Jun 2022
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jyoti Burad, Sultan Qaboos University
- Investigators
- Jyoti Burad, MD, EDIC, Principal investigator, Sultan Qaboos University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549427
- Sponsor's protocol ID
- MREC#2783
- Acronym
- VAP-MDR
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 28189513Patil 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.
PubMed 28250674Gupta 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.
PubMed 28288860Grasselli 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.
PubMed 33857475Sangale 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.
PubMed 34045810Papazian 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.
PubMed 32157357
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on Ventilator Associated Pneumonia Caused by Multi-Drug Resistance Organism in SQUH ICU
- ClinicalTrials.gov ID
- NCT05549427
- Acronym / sponsor ID
- VAP-MDR / MREC#2783
- Keywords
- Ventilator Associated Pneumonia, Multi drug resistance, antibiotics, length of stay, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- is to find the incidence of VAP in ICU patients.
- to find outcomes for VAP patients.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Non-ventilated patients.
- Patient with tracheobronchitis
- Patients positive for fungal cultures
- Patients with pneumonia before intubation
- Non-MDR VAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VentilationVentilation in ICU | Other | – |
Primary outcome
Distribution of Multi-Drug Resistant (MDR) bacteria in VAP positive patients
Time frame: upto 90 days
Frequency and classes of MDR organisms isolated from respiratory specimens of ventilated patients for more than 48 hours
3 secondary outcomes
Incidence of MDR-VAP in ICU patients
Time frame: upto 90 days
Outcome of MDR-VAP patients
Time frame: upto 90 days
Antibiotic sensitivity for MDR-VAP causing organism
Time frame: upto 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 28189513Djordjevic 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.
- Background: PubMed 28250674Patil 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.
- Background: PubMed 28288860Gupta 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.
- Background: PubMed 33857475Grasselli 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.
- Background: PubMed 34045810Sangale 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.
- Background: PubMed 32157357Papazian 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jyoti Burad, MD, EDIC principal investigator
Sultan Qaboos University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia and Multi-antibiotic Resistance, run by Sultan Qaboos University at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Multi-Drug Resistant (MDR) bacteria in VAP positive patients (time frame: upto 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549427, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.