Detection of Colistin-resistant Isolates From Patients of Intensive Care Units and Oncohaematology Wards. (RESCO)

Detection of Colistin-resistant Isolates From Patients Admitted in Intensive Care Units and Oncohaematology Wards in the Region Nouvelle Aquitaine: Diagnostic Accuracy of the Detection Methods, Estimation of the Prevalence and Description of the Resistance Mechanisms.

The increasing use of colistin in multidrug resistant strains, as Enterobacteriaceae producing extended-spectrum β-lactamases or carbapenemases, is associated with the emergence of colistin resistant isolates. The main objective of this project is to estimate the diagnostic accuracy (sensitivity and specificity) of a new rapid detection test of colistin resistant strains (Rapid Polymyxin NP test) isolated in clinical settings.

Study Overview

• Status: Completed
• Conditions: Colistin Resistance in Bacteria
• Intervention / Treatment: Diagnostic test: Rapid Polymyxin NP test

Detailed Description

For 15 years, the prevalence of the extended-spectrum β-lactamases producing Enterobacteriaceae (ESBLE), resistant to the 3rd generation cephalosporins, has constantly increased worldwide. Since 2010 an additional threat appeared with the emergence of the bacteria resistant to carbapenems, the antibiotic of choice in case of infection due to ESBLE. To treat the infection due to these extremely resistant strains, there are still only few molecules, as the colistin. Very quickly, the colistin resistance appeared, especially a plasmid-born resistance described in December 2015 and which has already spread a lot, most probably from an animal reservoir. The control of the resistance dissemination requires reliable tools for detection of colistin resistant isolates, in particular in immunocompromised patients, as those of intensive care unit (ICU) or oncohaematology ward, that are often exposed to multidrug resistant strains. Currently, the colistin resistance is difficult to detect and that is probably why it was underestimated for a long time and has already diffuse worldwide. Some recent tests for the detection of colistin resistant isolates have been developed and tested in laboratory. They have now to be evaluated in clinical situation in order to be correctly used and interpreted. From rectal swabs of patients admitted in ICU and oncohaematology ward, investigators will use first a new culture medium (SuperPolymyxin) for screening the colistin resistant Gram negative bacteria and then a new rapid test (Rapid Polymyxin NP test) to confirm this resistance. These tests will be compared to the reference test of MIC (Minimal Inhibitory Concentration) determined by the broth micro-dilution (BMD) method. The isolates will be collected on the screening medium, during 12 months, from 4 centers (Mont de Marsan, Limoges, Dax, Bordeaux) and sent to Bordeaux University Hospital where the rapid test and the BMD method will be centralized.

• Study Type: Observational
• Enrollment (Actual): 1934

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux
  • Dax, France, 40107
    • CH de Dax
  • Limoges, France, 87000
    • CHU de Limoges
  • Mont-de-Marsan, France, 40024
    • CH de Mont de Marsan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted in ICU or in oncohaematology ward

Description

Inclusion Criteria:

• patients ≥ 18 years old
• patients admitted in ICU or in oncohaematology ward

Exclusion Criteria:

- Patients under protection of justice

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients admitted in ICU or oncohaematology ward

Diagnostic test: Rapid Polymyxin NP test; From rectal swabs of patients admitted in ICU and oncohaematology ward, investigators will use first a new culture medium (SuperPolymyxin) for screening the colistin resistant Gram negative and then a new rapid test (Rapid Polymyxin NP test) to confirm this resistance. These tests will be compared to the reference test of MIC (Minimal Inhibitory Concentration) determined by the broth micro-dilution (BMD) method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of Rapid Polymyxin NP test	Up to 1 year after Inclusion (rectal swab or stool collection)
Specificity of Rapid Polymyxin NP test	Up to 1 year after Inclusion (rectal swab or stool collection)

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence rate of the colistin resistance	Up to 1 year after Inclusion (rectal swab or stool collection)
Bacterial species found resistant	Up to 1 year after Inclusion (rectal swab or stool collection)
Characterization of the various colistin resistance mechanisms	Up to 1 year after Inclusion (rectal swab or stool collection)
Identification of the genetic support of the resistance (plasmid or chromosome)	Up to 1 year after Inclusion (rectal swab or stool collection)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Paul PEREZ, MD-PhD, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): February 16, 2021
• Study Completion (Actual): February 16, 2021

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ICU; Rectal swab; Colistin resistance in bacteria; Oncohaematology; Gram negative bacteria
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Polymyxins
• Other Study ID Numbers: CHUBX 2016/45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No