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Nosocomial PneumoniaCOLOCOLINCT03303937

Characteristics of Lower Respiratory Tract Escherichia Coli Isolates in Mechanically Ventilated Intensive Care Patients

An observational study of Nosocomial Pneumonia and Ventilator Associated Pneumonia, run by Hôpital Louis Mourier.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
289 participants
Where
No sites listed yet
Study dates
27 Mar 2012to 6 Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • -

About this study

Official title: Characteristics of Lower Respiratory Tract Escherichia Coli Isolates Colonizing and Infecting Mechanically Ventilated Intensive Care Patients: a French Multicenter Prospective Collection

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.

Read the 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.

Keywords
virulence factor genes;, phenotyping, genotyping, antimicrobial susceptibility
Medical subject headings
Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated, Escherichia coli Infections, Diarrhea

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 50 minutes

Secondary outcomes (4)

  1. O-type determination

    polymerase chain reaction (PCR) method was used to search for the most anticipated serotypes in extra-intestinal infections : O1, O2a, O2b, O4, O6, O7, O12, O15, O16, O17, O18, O22, O25a, O25b, O45a, O75, O78

    Measured: 50 minutes

  2. virulence factor (VF) gene content determination

    Multiplex PCR was used to detect genes encoding for eleven frequently encountered extraintestinal VFs (S and F fimbriae (sfa/foc), pili associated with pyelonephritis (papC), P adhesin (papGII, papGIII), the ferric yersiniabactin uptake receptor (fyuA), iron transport (iroN), aerobactin (aer), conjugal transfer protein (traT), N-acetylglucosamine 2-epimerase protein (neuC), hemolysin (hlyC), and the cytotoxic necrotizing factor 1(cnf1)

    Measured: 90 minutes

  3. antimicrobial susceptibility determination

    Antimicrobial susceptibility of each isolate was determined by disk-diffusion method according to the French Society of Microbiology. Resistance score was defined as the sum of inactive in vitro antimicrobial agents for each isolate

    Measured: 24 hours

  4. presence of betalactamase

    Detection of gene sequences coding for the CTX-M and TEM enzymes was performed by PCR with genomic DNA

    Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2017
  2. Study start27 Mar 2012
  3. Primary completion10 Jun 2015
  4. Study completion6 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03303937
Sponsor's protocol ID
HLM_JDR8
Acronym
COLOCOLI
Status last verified
Oct 2017
First submitted
25 Sep 2017
Last updated
6 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23052953

  • 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.

    PubMed 27387322

  • 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.

    PubMed 26822436

  • 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.

    PubMed 21177892

  • 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.

    PubMed 34245272

Questions about this trial

What is this clinical trial studying?

An observational study of Nosocomial Pneumonia and Ventilator Associated Pneumonia, run by Hôpital Louis Mourier.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

phylogenetic group determination (time frame: 50 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03303937, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.

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