PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

Ventilator Associated Pneumonia Clinical Trial

Official title:

PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05486130
• Other study ID #: PRECEPT
• Status: Active, not recruiting
• Start date: July 18, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. Cephalosporinase-producing Enterobacteriaceae have an increasing incidence. Infections in cephalosporinase-producing patients require the use of Cefepime during probabilistic antibiotic therapy, the repeated use of which will lead to a significant risk of selection of resistant mutants. The involvement of cephalosporinases being infrequent, the prediction of their presence during a VAP would make it possible to reduce the consumption of Cefepime and thus to take part in the prevention of selection of bacterial mutants resistant to beta-lactams. The main objective of the research is to determine the risk factors for the involvement of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia (VAP) in hospitalized patients. The secondary objectives are to describe the epidemiology of cephalosporinase-producing enterobacteria in the ICU and to compare the risk factors for the presence of a cephalosporinase-producing germ not without its production being derepressed with those present in situations of cephalosporinase derepression.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 345
• Est. completion date: December 31, 2023
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient 18 years and older

• Patient on mechanical ventilation for more than 48 hours

• Patient with a diagnosis of ventilator-associated lung disease during management according to American Thoracic Society criteria

• French speaking patient

Exclusion Criteria:

• Tracheostomized patient at the time of inclusion

• Limitation of therapies before inclusion in the study

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Patient under court protection

• Patient objecting to the use of his/her data for this research

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (6)

Bouadma L, Sonneville R, Garrouste-Orgeas M, Darmon M, Souweine B, Voiriot G, Kallel H, Schwebel C, Goldgran-Toledano D, Dumenil AS, Argaud L, Ruckly S, Jamali S, Planquette B, Adrie C, Lucet JC, Azoulay E, Timsit JF; OUTCOMEREA Study Group. Ventilator-Associated Events: Prevalence, Outcome, and Relationship With Ventilator-Associated Pneumonia. Crit Care Med. 2015 Sep;43(9):1798-806. doi: 10.1097/CCM.0000000000001091. — View Citation

Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078. — View Citation

Crnich CJ, Safdar N, Maki DG. The role of the intensive care unit environment in the pathogenesis and prevention of ventilator-associated pneumonia. Respir Care. 2005 Jun;50(6):813-36; discussion 836-8. — View Citation

Damas P, Layios N, Seidel L, Nys M, Melin P, Ledoux D. Severity of ICU-acquired pneumonia according to infectious microorganisms. Intensive Care Med. 2011 Jul;37(7):1128-35. doi: 10.1007/s00134-011-2255-8. Epub 2011 May 26. — View Citation

Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754. — View Citation

Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J. National trends in patient safety for four common conditions, 2005-2011. N Engl J Med. 2014 Jan 23;370(4):341-51. doi: 10.1056/NEJMsa1300991. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia	This outcome corresponds to the the number of ventilator-associated pneumonias involving cephalosporinase-producing enterobacteria.	1 month
Secondary	Epidemiology of cephalosporinase-carrying enterobacteria in the ICU	This outcome corresponds to the number of pathogens identified in ventilator-associated pneumonia.	1 month