Clinical trial NCT03303937: Characteristics of Lower Respiratory Tract Escherichia Coli Isolates in Mechanically Ventilated Intensive Care Patients
Official title: Characteristics of Lower Respiratory Tract Escherichia Coli Isolates Colonizing and Infecting Mechanically Ventilated Intensive Care Patients: a French Multicenter Prospective Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Pneumonia
Ventilator Associated Pneumonia
Escherichia Coli Infections
Escherichia Coli Pneumonia
Escherichia Coli; Diarrhea, Enteroaggregative
Mechanical Ventilation Complication
Keywords: virulence factor genes;
phenotyping
genotyping
antimicrobial susceptibility
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any adult critically ill patient admitted to the ICU under invasive mechanical ventilation with a positive lower respiratory tract sample for Escherichia coli

Brief summary: Prospective, multicenter observational study to collect Escherichia coli (E. coli) isolates originating from mechanically ventilated intensive care unit (ICU) patients; in order to characterize phenotype and genotype of E. coli strains retrieved from the lower respiratory tract of ventilated patients.

Detailed description: Prospective, observational, multiple center study performed in 14 ICUs in France to collect Escherichia coli (E. coli) isolates originating from mechanically ventilated intensive care unit (ICU) patients; in order to characterize phenotype and genotype of E. coli strains retrieved from the lower respiratory tract of ventilated patients. All E. coli isolates identified in the microbiology lab and retrieved from a lung specimen (either tracheal aspirate, bronchoalveolar lavage, or telescopic plugged catheter) originating from an ICU patient will be kept, and stored at -80°C in brain-heart infusion broth containing glycerol 20 %. They will be then centralized in the investigators' research unit for further analysis that includes determination of Antimicrobial susceptibility, E. coli phylotype , O-type, and virulence factor gene content.

These isolates will be compared to those of two previously published collections, one from the stools of community subjects, considered as commensal strains, the other from the blood of bacteraemia patients.

Eligibility criteria: Inclusion Criteria:

* adult, admitted to the intensive care unit
* under invasive mechanical ventilation
* presence of Escherichia coli in lower respiratory tract specimen

Exclusion Criteria:

-

Primary outcomes:
measure: phylogenetic group determination
timeFrame: 50 minutes
Secondary outcomes:
measure: O-type determination
timeFrame: 50 minutes
measure: virulence factor (VF) gene content determination
timeFrame: 90 minutes
measure: antimicrobial susceptibility determination
timeFrame: 24 hours
measure: presence of betalactamase
timeFrame: 90 minutes
Other outcomes:
measure: phylogenetic group belonging in other existing Escherichia coli collections
timeFrame: 24 hours
measure: O-type distribution in other existing Escherichia coli collections
timeFrame: 24 hours
measure: virulence factor (VF) gene content in other existing Escherichia coli collections
timeFrame: 24 hours
measure: phylogenetic group belonging in E. coli isolates responsible for pneumonia and in those responsible for simple colonization
timeFrame: median time frame is 11.5 days with a maximum of 35 days
measure: O-type distribution in E. coli isolates responsible for pneumonia and in those responsible for simple colonization
timeFrame: median time frame is 11.5 days with a maximum of 35 days
measure: virulence factor (VF) gene content in E. coli isolates responsible for pneumonia and in those responsible for simple colonization
timeFrame: median time frame is 11.5 days with a maximum of 35 days
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Damien Ricard, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Béatrice La Combe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messika J, Magdoud F, Clermont O, Margetis D, Gaudry S, Roux D, Branger C, Dreyfuss D, Denamur E, Ricard JD. Pathophysiology of Escherichia coli ventilator-associated pneumonia: implication of highly virulent extraintestinal pathogenic strains. Intensive Care Med. 2012 Dec;38(12):2007-16. doi: 10.1007/s00134-012-2699-5. Epub 2012 Sep 28.
citation: Dufour N, Clermont O, La Combe B, Messika J, Dion S, Khanna V, Denamur E, Ricard JD, Debarbieux L; ColoColi group. Bacteriophage LM33_P1, a fast-acting weapon against the pandemic ST131-O25b:H4 Escherichia coli clonal complex. J Antimicrob Chemother. 2016 Nov;71(11):3072-3080. doi: 10.1093/jac/dkw253. Epub 2016 Jul 7.
citation: Massot M, Daubie AS, Clermont O, Jaureguy F, Couffignal C, Dahbi G, Mora A, Blanco J, Branger C, Mentre F, Eddi A, Picard B, Denamur E, The Coliville Group. Phylogenetic, virulence and antibiotic resistance characteristics of commensal strain populations of Escherichia coli from community subjects in the Paris area in 2010 and evolution over 30 years. Microbiology (Reading). 2016 Apr;162(4):642-650. doi: 10.1099/mic.0.000242. Epub 2016 Jan 28.
citation: Lefort A, Panhard X, Clermont O, Woerther PL, Branger C, Mentre F, Fantin B, Wolff M, Denamur E; COLIBAFI Group. Host factors and portal of entry outweigh bacterial determinants to predict the severity of Escherichia coli bacteremia. J Clin Microbiol. 2011 Mar;49(3):777-83. doi: 10.1128/JCM.01902-10. Epub 2010 Dec 22.
citation: Royer G, Poirel L, La Combe B, Clermont O, Chau F, Mercier-Darty M, Denamur E, Nordmann P, Ricard JD, Decousser JW. Lack of association between colistin resistance and chlorhexidine reduced susceptibility in clinical isolates of Escherichia coli. J Antimicrob Chemother. 2021 Sep 15;76(10):2736-2737. doi: 10.1093/jac/dkab235. No abstract available.