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

Klebsiella Infections Clinical Trial

— PoKES2_HYDRES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05193045
• Other study ID #: PoKES2_HYDRES
• Status: Active, not recruiting
• Start date: October 28, 2021
• 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 31, 2023
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Klebsiella Infections

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 (7)

Brun-Buisson C, Meshaka P, Pinton P, Vallet B; EPISEPSIS Study Group. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. 2004 Apr;30(4):580-8. doi: 10.1007/s00134-003-2121-4. Epub 2004 Mar 2. — View Citation

de Grooth HJ, Postema J, Loer SA, Parienti JJ, Oudemans-van Straaten HM, Girbes AR. Unexplained mortality differences between septic shock trials: a systematic analysis of population characteristics and control-group mortality rates. Intensive Care Med. 2018 Mar;44(3):311-322. doi: 10.1007/s00134-018-5134-8. Epub 2018 Mar 15. — View Citation

Prescott HC, Angus DC. Enhancing Recovery From Sepsis: A Review. JAMA. 2018 Jan 2;319(1):62-75. doi: 10.1001/jama.2017.17687. — View Citation

Rhee C, Dantes R, Epstein L, Murphy DJ, Seymour CW, Iwashyna TJ, Kadri SS, Angus DC, Danner RL, Fiore AE, Jernigan JA, Martin GS, Septimus E, Warren DK, Karcz A, Chan C, Menchaca JT, Wang R, Gruber S, Klompas M; CDC Prevention Epicenter Program. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836. — View Citation

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. — View Citation

Shankar-Hari M, Harrison DA, Ferrando-Vivas P, Rubenfeld GD, Rowan K. Risk Factors at Index Hospitalization Associated With Longer-term Mortality in Adult Sepsis Survivors. JAMA Netw Open. 2019 May 3;2(5):e194900. doi: 10.1001/jamanetworkopen.2019.4900. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU	This outcome corresponds to the mortality in intensive care.	Day 128
Secondary	Evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system) at day 28	This outcome corresponds to the mortality rate at day 28.	Day 28
Secondary	Evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system) at 3 months.	This outcome corresponds to the mortality rate at 3 months.	Month 3