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

Mechanical Ventilation Complication Clinical Trial

— COLOCOLI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303937
• Other study ID #: HLM_JDR8
• Status: Completed
• Phase: N/A
• First received: September 25, 2017
• Last updated: October 5, 2017
• Start date: March 27, 2012
• Est. completion date: June 6, 2016

Study information

• Verified date: October 2017
• Source: Hôpital Louis Mourier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: June 6, 2016
• Est. primary completion date: June 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult, admitted to the intensive care unit

• under invasive mechanical ventilation

• presence of Escherichia coli in lower respiratory tract specimen

Exclusion Criteria:

Related Conditions & MeSH terms

• Diarrhea
• Escherichia coli Infections
• Escherichia Coli Pneumonia
• Escherichia Coli; Diarrhea, Enteroaggregative
• Mechanical Ventilation Complication
• Nosocomial Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

References & Publications (4)

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. Epub 2016 Jul 7. — View Citation

Lefort A, Panhard X, Clermont O, Woerther PL, Branger C, Mentré 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. — View Citation

Massot M, Daubié AS, Clermont O, Jauréguy F, Couffignal C, Dahbi G, Mora A, Blanco J, Branger C, Mentré 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. 2016 Apr;162(4):642-50. doi: 10.1099/mic.0.000242. Epub 2016 Jan 28. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	24 hours
Other	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)	24 hours
Other	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)	24 hours
Other	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	median time frame is 11.5 days with a maximum of 35 days
Other	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	median time frame is 11.5 days with a maximum of 35 days
Other	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	median time frame is 11.5 days with a maximum of 35 days
Primary	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	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	50 minutes
Secondary	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)	90 minutes
Secondary	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	24 hours
Secondary	presence of betalactamase	Detection of gene sequences coding for the CTX-M and TEM enzymes was performed by PCR with genomic DNA	90 minutes