NCT03303937

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

3.2 years

First QC Date

September 25, 2017

Last Update Submit

October 5, 2017

Conditions

Keywords

virulence factor genes;phenotypinggenotypingantimicrobial susceptibility

Outcome Measures

Primary Outcomes (1)

  • phylogenetic group determination

    Quadruplex polymerase chain reaction (PCR) method was used to determine the E. coli phylogenetic group (A, B1, B2, C, D, E, F), or Escherichia clade I belonging

    50 minutes

Secondary Outcomes (4)

  • O-type determination

    50 minutes

  • virulence factor (VF) gene content determination

    90 minutes

  • antimicrobial susceptibility determination

    24 hours

  • presence of betalactamase

    90 minutes

Other Outcomes (6)

  • phylogenetic group belonging in other existing Escherichia coli collections

    24 hours

  • O-type distribution in other existing Escherichia coli collections

    24 hours

  • virulence factor (VF) gene content in other existing Escherichia coli collections

    24 hours

  • +3 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 23052953BACKGROUND
  • 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.

    PMID: 27387322BACKGROUND
  • 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.

    PMID: 26822436BACKGROUND
  • 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.

    PMID: 21177892BACKGROUND
  • 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.

MeSH Terms

Conditions

Healthcare-Associated PneumoniaPneumonia, Ventilator-AssociatedEscherichia coli InfectionsDiarrhea

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSigns and Symptoms, DigestiveSigns and Symptoms

Study Officials

  • Jean-Damien Ricard, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR
  • Béatrice La Combe, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Intensive Care

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 6, 2017

Study Start

March 27, 2012

Primary Completion

June 10, 2015

Study Completion

June 6, 2016

Last Updated

October 6, 2017

Record last verified: 2017-10