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Completed

NCT Number: NCT03303937

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

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.

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Key information

Conditions

Nosocomial Pneumonia Bacterial Infections Bacterial Infections and Mycoses Cross Infection Diarrhea Disease Attributes Enterobacteriaceae Infections Escherichia Coli Infections Escherichia Coli Pneumonia Escherichia Coli; Diarrhea, Enteroaggregative Gram-Negative Bacterial Infections Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Mechanical Ventilation Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Ventilator Associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. phylogenetic group determination

    Time frame: 50 minutes

    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

Secondary outcomes

  1. O-type determination

    Time frame: 50 minutes

    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

  2. virulence factor (VF) gene content determination

    Time frame: 90 minutes

    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)

  3. antimicrobial susceptibility determination

    Time frame: 24 hours

    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

  4. presence of betalactamase

    Time frame: 90 minutes

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

Other outcomes

  1. phylogenetic group belonging in other existing Escherichia coli collections

    Time frame: 24 hours

    comparison of phylogenetic group belonging of the present isolates to those of two previously published collections, originating from the Paris area, France; one that comprises 280 E. coli strains isolated from the stools of community adult subjects in 2010 ("COLIVILLE") and that can be considered as commensal strains and the other that comprises 373 E. coli strains isolated from the blood of 373 patients hospitalized in seven different hospitals, during the course of bacteraemia in 2005 (COLIBAFI study)

  2. O-type distribution in other existing Escherichia coli collections

    Time frame: 24 hours

    comparison of O-type distribution of the present isolates to those of two previously published collections, originating from the Paris area, France; one that comprises 280 E. coli strains isolated from the stools of community adult subjects in 2010 ("COLIVILLE") and that can be considered as commensal strains and the other that comprises 373 E. coli strains isolated from the blood of 373 patients hospitalized in seven different hospitals, during the course of bacteraemia in 2005 (COLIBAFI study)

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

    Time frame: 24 hours

    comparison of virulence factor (VF) gene content of the present isolates to those of two previously published collections, originating from the Paris area, France; one that comprises 280 E. coli strains isolated from the stools of community adult subjects in 2010 ("COLIVILLE") and that can be considered as commensal strains and the other that comprises 373 E. coli strains isolated from the blood of 373 patients hospitalized in seven different hospitals, during the course of bacteraemia in 2005 (COLIBAFI study)

  4. phylogenetic group belonging in E. coli isolates responsible for pneumonia and in those responsible for simple colonization

    Time frame: median time frame is 11.5 days with a maximum of 35 days

    comparison of phylogenetic group belonging between isolates responsible for pneumonia and those for simple colonization

  5. O-type distribution in E. coli isolates responsible for pneumonia and in those responsible for simple colonization

    Time frame: median time frame is 11.5 days with a maximum of 35 days

    comparison of O-type distribution between isolates responsible for pneumonia and those for simple colonization

  6. virulence factor (VF) gene content in E. coli isolates responsible for pneumonia and in those responsible for simple colonization

    Time frame: median time frame is 11.5 days with a maximum of 35 days

    comparison of virulence factor (VF) gene content between isolates responsible for pneumonia and those for simple colonization

Sponsors and collaborators

Lead sponsor

Hôpital Louis Mourier

Other

Registry information

Official study title

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

Acronym: COLOCOLI

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 6, 2017
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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