Colistin Resistance in BacteriaRESCONCT03971877
Detection of Colistin-resistant Isolates From Patients of Intensive Care Units and Oncohaematology Wards.
An observational study of Colistin Resistance in Bacteria, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colistin Resistance in Bacteria
- What is being tested?
- Rapid Polymyxin NP test
- How many people
- 1,934 participants
- Where
- 4 sitesFrance
- Study dates
- 16 Dec 2019to 16 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in ICU or in oncohaematology ward
Who may be able to join
- patients ≥ 18 years old
- patients admitted in ICU or in oncohaematology ward
Who cannot join
- Patients under protection of justice
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Bordeaux
Bordeaux, 33076
CH de Dax
Dax, 40107
CHU de Limoges
Limoges, 87000
CH de Mont de Marsan
Mont-de-Marsan, 40024
About this study
Official title: 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.
Read the 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.
- Conditions
- Colistin Resistance in Bacteria
- Being tested
- Rapid Polymyxin NP test
- Keywords
- Colistin resistance in bacteria, Rectal swab, ICU, Oncohaematology, Gram negative bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Polymyxin NP testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted in ICU or oncohaematology ward | Not described Receives: Diagnostic Test: Rapid Polymyxin NP test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Rapid Polymyxin NP test
Measured: Up to 1 year after Inclusion (rectal swab or stool collection)
Specificity of Rapid Polymyxin NP test
Measured: Up to 1 year after Inclusion (rectal swab or stool collection)
Secondary outcomes (4)
Prevalence rate of the colistin resistance
Measured: Up to 1 year after Inclusion (rectal swab or stool collection)
Bacterial species found resistant
Measured: Up to 1 year after Inclusion (rectal swab or stool collection)
Characterization of the various colistin resistance mechanisms
Measured: Up to 1 year after Inclusion (rectal swab or stool collection)
Identification of the genetic support of the resistance (plasmid or chromosome)
Measured: Up to 1 year after Inclusion (rectal swab or stool collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start16 Dec 2019
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colistin Resistance in BacteriaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,934 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, MD-PhD, Study chair, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971877
- Sponsor's protocol ID
- CHUBX 2016/45
- Acronym
- RESCO
- Status last verified
- Mar 2022
- First submitted
- 29 May 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03971877
- Acronym / sponsor ID
- RESCO / CHUBX 2016/45
- Conditions
- Colistin Resistance in Bacteria
- Keywords
- Colistin resistance in bacteria, Rectal swab, ICU, Oncohaematology, Gram negative bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,934 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted in ICU or oncohaematology ward | – | Diagnostic Test: Rapid Polymyxin NP test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU or in oncohaematology ward
Key inclusion criteria (2 listed)
- patients ≥ 18 years old
- patients admitted in ICU or in oncohaematology ward
Key exclusion criteria (1 listed)
- Patients under protection of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Polymyxin NP testFrom 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. | Diagnostic test | Patients admitted in ICU or oncohaematology ward |
Primary outcome
Sensitivity of Rapid Polymyxin NP test
Time frame: 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)
4 secondary outcomes
Prevalence rate of the colistin resistance
Time frame: 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)
Characterization of the various colistin resistance mechanisms
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
Related trials for Colistin Resistance in Bacteria
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Bacteremia Caused by Gram-Negative Bacteria, Bacterial Pneumonia
Active, not recruitingPhase 4
Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul PEREZ, MD-PhD study chair
Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colistin Resistance in Bacteria, run by University Hospital, Bordeaux at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Rapid Polymyxin NP test (time frame: Up to 1 year after Inclusion (rectal swab or stool collection)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.