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

March 11, 2022 updated by: University Hospital, Bordeaux

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1934

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sensitivity of Rapid Polymyxin NP test
Time Frame: Up to 1 year after Inclusion (rectal swab or stool collection)
Up to 1 year after Inclusion (rectal swab or stool collection)
Specificity of Rapid Polymyxin NP test
Time Frame: Up to 1 year after Inclusion (rectal swab or stool collection)
Up to 1 year after Inclusion (rectal swab or stool collection)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Prevalence rate of the colistin resistance
Time Frame: Up to 1 year after Inclusion (rectal swab or stool collection)
Up to 1 year after Inclusion (rectal swab or stool collection)
Bacterial species found resistant
Time Frame: Up to 1 year after Inclusion (rectal swab or stool collection)
Up to 1 year after Inclusion (rectal swab or stool collection)
Characterization of the various colistin resistance mechanisms
Time Frame: Up to 1 year after Inclusion (rectal swab or stool collection)
Up to 1 year after Inclusion (rectal swab or stool collection)
Identification of the genetic support of the resistance (plasmid or chromosome)
Time Frame: Up to 1 year after Inclusion (rectal swab or stool collection)
Up to 1 year after Inclusion (rectal swab or stool collection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Paul PEREZ, MD-PhD, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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