Why participate?

Despite general advances in the management of ICU patients, nosocomial pneumonia remains a major problem in the critical care setting [1-3]. It has been reported as the second most common Health-care Associated Infection (HAI), the most common nosocomial infection in the ICU and the most common nosocomial infection contributing to death. As well, there is a lack of concordance between the diagnosis of nosocomial pneumonia in routine clinical practice and the official definitions including: a) ATS/IDSA 2005 guidelines [1]; b) CDC/NHSN Surveillance Definitions (version January 2015, modified April 2015) [4, 5].  Therefore, it is evident why PneumoINSPIRE, as an international large-sample size study, is relevant and important in closing the knowledge gaps still evident on the subject matter of ICU-based nosocomial pneumonia.

Hospital hallVentilator Acquired Pneumonia (VAP) accounts for more than half of all ICU antibiotic prescriptions and is associated with significant crude mortality rates, ranging from 20-71% [1-3]. Although controversy exists, most experts suggest that the attributable to VAP mortality is 33-55% [1]. In addition, VAP is associated with an average increase of hospital length of stay by 7-9 days and increased health-care costs of more than 40,000 US$ per patient [1]. Especially for nosocomial pneumonia in non-intubated ICU patients, it should be emphasized that studies are limited with most information arbitrary extrapolated from studies on VAP [1].”

Successful treatment of nosocomial pneumonia remains difficult and complex [1]. Initial empiric antibiotic treatment, in terms of timeliness, dose and spectrum of cover, is a key element for effective management, with higher morbidity, mortality and cost associated with inappropriate treatment [1-3, 6]. Up-to-date, global data about the everyday clinical practice regarding the treatment as well as de-escalation and discontinuation practices and their effect on outcomes, would be an essential step in the development of interventions to improve and rationalise treatment choices.

Finally, the existing literature is scarce regarding clinical characteristics and outcomes of nosocomial pneumonia in specific ICU sub-groups (e.g. patients with chronic obstructive pulmonary disease (COPD) [7-9] or the elderly ones [10]). A large cohort study would improve understanding and assist in identifying optimised treatment approaches for these specific patients groups in the ICU.

PneumoINSPIRE ultimately aims to obtain quality data regarding the impact of nosocomial pneumonia worldwide. The need for greater understanding regarding pneumonia is apparent. Efforts made with this project will help move global healthcare practitioners toward standardization of care and the reduction of mortality related to nosocomial pneumonia.   

Endorsements

ESICM logoPneumoINSPIRE study has been endorsed by the European Society of Intensive Care Medicine (ESICM).

Ethics approval

This study will be conducted in accordance with the ethical principles laid down by the International Conference on Harmonization guidelines for Good Clinical Practice (GCP) that have their origin in the Declaration of Helsinki and the applicable local regulatory requirements.

 

This study is considered to be low-negligible risk as is an observational, non-interventional study with collection of de-identified data. Each participating ICU will seek relevant EC and institutional approvals, including a waiver of ethics review where appropriate. A waiver of individual participant consent will be sought for collection of de-identified clinical data recorded as part of routine clinical care. The NCs and LPIs will be responsible for determining the need for relevant national and local site EC approvals and obtaining it if needed, respectively.

 

As PneumoINSPIRE is an observational study, usually Ethics approval is not time-consuming (or can, in certain cases, be waived as for several sites it is considered an audit). We are happy to help with the process if required. No translation of Ethics approval in English is needed.

 

Participating Sites

PneumoINSPIRE contributors

Pneumonia has a wide-ranging and diverse impacts on ICUs across the world. It is these various impacts and motivators that attract researchers worldwide to the PneumoINSPIRE study.  Below is feedback from some of our major collaborators and national coordinators regarding pneumonia’s affect on their ICU and why they decided to participate in PneumoINSPIRE. 

 

Kostoula Arvaniti, Monitoring Committee &  National Coordinator of Greece

PneumoINSPIRE appeared since the beginning as a really ambitious project on a common clinical entity in the ICU setting, endorsed by important scientific societies. The prospective and multinational multicentre design of the study was promising regarding collection or real-world data on diagnostic and therapeutic management of hospital- and ventilator-associated pneumonia patients. Moreover, it aims to give to each ICU center and country, a great opportunity for rational comparisons between their own setting and the international cohort, thus facilitating future prevention and treatment strategies amelioration. Pneumonia remains a principal cause of ICU admission and an important cause of overall mortality despite numerous scientific advances on prevention and treatment policies. I hope the results from this international database will help identify specific risk factors of mortality and parameters affecting appropriate antibiotic treatment (e.g. multidrug resistance, inadequately performed diagnostic procedures, confused scientific guidelines on appropriateness and indication of various diagnostic sampling techniques, ICU and hospital organizational issues, etc.)


Jordi Rello, Steering Committee & National Coordinator of  Spain

This project will show a real picture on the complexity and diversity of respiratory infections in MV patients. PneumoINSPIRE is a global collaborative effort to advance on the challenge of updating the understanding of VAP. An old-problem. A new perspective.


Vladimir Shatalov, Principal Investigator of Core Site in Russia

In our ICU, nosocomial pneumonia often develops in patients undergoing prolonged mechanical ventilation. Most of these patients have acute brain damage (stroke, trauma). In patients with another pathologies, nosocomial pneumonia develops quite rarely. In this study, I would like to know how nosocomial pneumonia is diagnosed in different countries, what the pathogens of pneumonia are more common and to what antibiotics they are most sensitive. I decided to participate in this study because it was interesting for me to work in a large international team of researchers. I wanted to get experience with observational study for my future work.


Jep Palo, National Coordinator of Philippines

We decided to participate in PneumoINSPIRE to understand our own patients with pneumonia, as well as to contribute to the world's knowledge for taking care of ICU patients with severe pneumonias. We thought it important, not only for the clinical aspect, but for the institutional learning that we gain from collaborating with researchers worldwide. Pneumonia is one of the top reasons for an admission to ICU in our Philippine setting and it was important to share our experience as well as audit our local practices.


Rosa Reina, National Coordinator of Argentina and Spanish protocol translator

This study will provide up-to-date and generalisable information on diagnosis and management of nosocomial pneumonia. Because this is a multi-centre study, carried out worldwide, PneumoINSPIRE will give us important information about nosocomial pneumonia.


Andrea Cortegiani, National Co-Coordinator of Italy & Principal Investigator of Core Site

Pneumonia is the most commonly encountered infection and is the most important complication of medium-long term mechanical ventilation. It is the clear main reason to try to speed up weaning process (in Italian, I would say "Damocle's sword over patient's head"). Big epidemiological studies are the only way to get useful information to improve the care of critically ill patients. PneumoINSPIRE has the methodological quality to be a landmark study With this study I hope to see more information on risk factors for pneumonia and treatment failure, prognosis and effects of different therapeutic strategies.


Boris Belotserkovski, Principal Investigator of Core Site in Russia

Pneumonia is a serious threat for my patients. Successful prevention and treatment of this complication in the era of high resistance will save a lot of lives. I hope to find out  the real epidemiological situation and etiology of nosocomial pneumonia in different countries. I don`t believe that the real rate on VAP is close to zero.

PneumoINSPIRE team

Sean Montgomery, Medical Student at the University of Queensland - Ochsner Clinical School

As a medical student from the United States, I chose to study in Australia because I am interested in the larger picture of medicine, which includes an appreciation for global health issues and practices. PneumoINSPIRE attracted me immediately because the study is seeking information from healthcare practitioners around the world. Understanding the methods surrounding the diagnosis, complications and treatment of pneumonia on a deeper level is of paramount importance. PneumoINSPIRE is an ambitious endeavor, and I am excited that my work on this project may help further knowledge surrounding pneumonia, ultimately reducing mortality for patients worldwide. 


Bruno Perthus, Medical Student at the University of Queensland - Ochsner Clinical School

I decided to volunteer as an extracurricular researcher for the PneumoINSPIRE study because as an aspiring Infectious Disease physician I have a strong interest in pneumonia. Pneumonia has such a profound effect on our global  healthcare system, and it is obvious that any progress that can be made to improve our knowledge, and thereby our treatment protocols, for this debilitating disease would be incredibly impactful. I am very excited and proud to be able to be a part of the PneumoINSPIRE study because I am aware that there are immense benefits that can be reaped from the data that is being collected

                                                                 

References

  1. American Thoracic Society & Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med 2005; 171:388-416
  2. Κoulenti D, Rello J. Hospital-acquired pneumonia in the 21st century: a review of current treatment options and their impact on patient care. Expert Opinion on Pharmacotherapy. 2006; 7:1555-1569
  3. Rello J, Lisboa T, Koulenti D. Respiratory infections in patients undergoing mechanical ventilation. Lancet Respir Med. 2014; 2(9):764-74                                                                                        
  4. Ventilator-Associated event (VAE) (For use in adult ICUs only). In: Device-associated Module, VAE, CDC January 2015 (modified April 2015), pages 10-1 to 10-41, accessed 28 September 2015, http://www.cdc.gov/nhsn/PDFs/pscManual/10- VAE_FINAL.pdf
  5. Pneumonia (Ventilator-associated [VAP] and non-ventilator-associated [PNEU]) Event, In: Device-associated Module, PNEU/VAP, CDC January 2015 (modified April 2015), pages 6-1 to 10-15, accessed 28 September 2015, http://www.cdc.gov/nhsn/PDFs/pscManual/6pscVAPcurrent.pdf                                
  6. Udy AA, Roberts JA, Lipman J. How should we dose antibiotics for pneumonia in the ICU? Curr Opin Infect Dis. 2013; 26:189-95.
  7. Nseir S, Di Pompeo C, Soubrier S, et al. Impact of ventilator-associated pneumonia on outcome in patients with COPD. Chest. 2005; 128:1650-6.
  8. Makris D, Desrousseaux B, Zakynthinos E, Durocher A, Nseir S. The impact ofCOPD on ICU mortality in patients with ventilator-associated pneumonia. Respir Med 2011;105(7):1022-9.
  9. Koulenti D, Blot S, Dulhunty J, et al., and the EU-VAP/CAP Study Group. COPD patients with ventilator-associated pneumonia: implications for management. Eur J Clin Microbiol Infect Dis. 2015 Sep25.   
  10. Blot S, Koulenti D, Dimopoulos et al. and the EU-VAP/CAP Study Group. Incidence, Risk Factors, and Mortality for Ventilator-Associated Pneumonia in Middle-Aged, Old, and Very-Old Critically Ill Patients. Crit Care Med 2014; 42:601-9