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.   

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

                                                                 

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.