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Prognosis of Klebsiella ESBL Sepsis: Role of 2-HYDRoxy-myristate in Endotoxin Structure (PoKES2_HYDRES)

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ClinicalTrials.gov Identifier: NCT05193045
Recruitment Status : Active, not recruiting
First Posted : January 14, 2022
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Infections constitute a multiple and heterogeneous set of pathologies, and the first cause of mortality worldwide. Among them, sepsis is a more recent nosological entity, including the most severe forms of acute infectious pathologies, its frequency increasing considerably over time. It is considered to be the cause of more than 27 million deaths per year, more than 4,000 deaths per day in the United States and about 200 deaths per day in intensive care units in France.

The occurrence of hemodynamic failure within visceral damage is a poor prognostic factor, the lethality in this situation can reach 60% of affected patients. The amount of organ dysfunction is also prognostic. More worryingly, the initial mortality is aggravated by the persistence of the negative evolution after hospital treatment, the 5-year prognosis being significantly more severe in the population of patients treated for sepsis than in the general population, particularly in the case of respiratory or cardiovascular damage during the stay in intensive care. The most frequent causes of these severe infections in the ICU are lower respiratory infections, particularly pneumonia acquired under mechanical ventilation, urinary tract infections and digestive tract infections.

Sepsis corresponds to an infection of particular severity, which results in the association of organ failures, the type and severity of which vary according to the patient, the origin of the infection and the pathogen responsible. The severity of the picture will require specific management and may necessitate the introduction of organ supplements or even lead to death in the most serious forms.

Infections by enterobacteria and in particular Klebsiella spp. are frequent in the intensive care unit. The association with antibiotic resistance and especially with ESBL production is a daily clinical situation. During these infections, the prognosis is variable, sometimes very poor, without it being possible to determine whether this evolution is due to antibiotic resistance or to the virulence of the pathogen. The objective of this work is to study the structure of lipid A of ESBL-producing Klebsiella strains responsible for nosocomial infections. This study is part of the "EVENT" protocols of which it is an ancillary analysis.

The objective of this study is to evaluate the role of the presence of 2-hydroxymyristate within lipid A of the lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU. The secondary objectives correspond to the evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system), and the presence of 2-hydroxymyristate and the risk of bacteremia.


Condition or disease
Klebsiella Infections

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognosis of Klebsiella ESBL Sepsis: Role of 2-HYDRoxy-myristate in Endotoxin Structure
Actual Study Start Date : October 28, 2021
Actual Primary Completion Date : November 28, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU [ Time Frame: Day 128 ]
    This outcome corresponds to the mortality in intensive care.


Secondary Outcome Measures :
  1. Evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system) at day 28 [ Time Frame: Day 28 ]
    This outcome corresponds to the mortality rate at day 28.

  2. Evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system) at 3 months. [ Time Frame: Month 3 ]
    This outcome corresponds to the mortality rate at 3 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
These patients were hospitalized in the ICU with nosocomial ESBL-producing Klebsiella infection between 2011 and 2016.
Criteria

Inclusion Criteria:

  • Patient whose age is ≥ 18 years
  • Patient hospitalized in an intensive care unit
  • Patient with a nosocomial infection with ESBL-producing Klebsiella
  • French-speaking patient

Exclusion Criteria:

  • Patient with a severe psychiatric disorder
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient who objects to the use of his or her data for this research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05193045


Locations
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France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Francois PHILIPPART, MD Groupe Hospitalier Paris Saint Joseph
Publications:
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT05193045    
Other Study ID Numbers: PoKES2_HYDRES
First Posted: January 14, 2022    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Klebsiella Infections
Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses