An observational study in Nosocomial Pneumonia, Ventilator Associated Pneumonia and Escherichia Coli Infections, sponsored by Hôpital Louis Mourier. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-06.
Sponsored by Hôpital Louis Mourier · Observational
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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.
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.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 83 are open to participants now.
This study's enrollment of 289 is above the median of 170 across 132 observational studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Hôpital Louis Mourier is the lead sponsor of 11 studies on the registry; none are open to participants now.
Compared within Pneumonia, Ventilator-Associated, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Healthcare-Associated Pneumonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
any adult critically ill patient admitted to the ICU under invasive mechanical ventilation with a positive lower respiratory tract sample for Escherichia coli
Exclusion Criteria:
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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
Time frame: 50 minutes
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
Time frame: 50 minutes
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)
Time frame: 90 minutes
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
Time frame: 24 hours
presence of betalactamase
Detection of gene sequences coding for the CTX-M and TEM enzymes was performed by PCR with genomic DNA
Time frame: 90 minutes
phylogenetic group belonging in other existing Escherichia coli collections
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)
Time frame: 24 hours
O-type distribution in other existing Escherichia coli collections
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)
Time frame: 24 hours
virulence factor (VF) gene content in other existing Escherichia coli collections
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)
Time frame: 24 hours
phylogenetic group belonging in E. coli isolates responsible for pneumonia and in those responsible for simple colonization
comparison of phylogenetic group belonging between isolates responsible for pneumonia and those for simple colonization
Time frame: median time frame is 11.5 days with a maximum of 35 days
O-type distribution in E. coli isolates responsible for pneumonia and in those responsible for simple colonization
comparison of O-type distribution between isolates responsible for pneumonia and those for simple colonization
Time frame: median time frame is 11.5 days with a maximum of 35 days
virulence factor (VF) gene content in E. coli isolates responsible for pneumonia and in those responsible for simple colonization
comparison of virulence factor (VF) gene content between isolates responsible for pneumonia and those for simple colonization
Time frame: median time frame is 11.5 days with a maximum of 35 days
No study locations are listed for this record.
Plan to share: Undecided
Ran from Mar 2012 to primary completion in Jun 2015, 38 months.
Of 63 non-industry observational studies under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 38 months is above that.
Counting every sponsor, half of 63 studies reached it within 20 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Pneumonia, Ventilator-Associated →
Hôpital Louis Mourier