Enterobacteria Non Susceptible to Carbapenem CarrierE-CARBNCT02127450
Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
An observational study of Enterobacteria Non Susceptible to Carbapenem Carrier and Enterobacteria Susceptible to Carbapenem Carrier, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production are one of the mechanisms of resistance to CARBA. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Enterobacteria Non Susceptible to Carbapenem Carrier, Enterobacteria Susceptible to Carbapenem Carrier
- How many people
- 525 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to May 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Patient hospitalised for more than 24 hours , with a clinical sample positive for a NS-CARB Enterobacteriaceae * Patient hospitalised for more than 24 hours with clinical sample positive for a non-NS-CARB Enterobacteriaceae and hospitalised in the same type of ward as that case * Patient hospitalised for more than 24 hours having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case, hospitalised in any type of ward in the hospital
Who may be able to join
- Case: Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae
- Control 1: Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae and hospitalised in the same type of ward as that case
- Control 2: Patient having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case, hospitalised in any type of ward in the hospital
Who cannot join
- the patient with digestive ER-CARB
Trial locations and contacts
1 site in 1 country.
About this study
The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in the routine in any laboratory is difficult. it will be useful to standardize them detection to control the emergence.
Read the detailed description
The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy because CARBA are often the alone antibiotics available to cure severe infections due to extended-spectrum β-lactamase (ESBL)-producing isolates. Two mechanisms of resistance to CARBA have been identified: membrane impermeability associated with ESBL or cephalosporinase production and carbapenemase (CARBase) production. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital in order to avoid the dissemination of the CARBase-producing strain and insure patient safety. Prevalence rate of non-susceptible (NS) isolates to CARB, the proportion of the two types of mechanisms of resistance to CARB and the factors associated with CARB- NS isolates are still unknown in France. Moreover, detecting CARBase in the routine in any laboratory is difficult. Providing data regarding all of these points will be useful for any hospital and will permit to optimize the management of the patients suspected or proved to harbor a CARBase-producing Enterobacteriaceae isolate.
- Conditions
- Enterobacteria Non Susceptible to Carbapenem Carrier, Enterobacteria Susceptible to Carbapenem Carrier
- Keywords
- Enterobacteriaceae, non-susceptible to carbapenem, carbapenemases, prevalence, screening algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case: NS-CARB positive | Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae | |
| Control 1: non-NS-CARB positive | Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae | |
| Control 2 : negative sample | Patient having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CARB-NS isolates and among them the proportion of those producing CARBase.
Determining the prevalence rate of CARB-NS isolates and among them the proportion of those producing CARBase for all enterobacterial species and for each species. CARBase production will be determined by using in a phenotypic algorithm previously established on the basis on commercialized tests and by molecular methods.
Determining by using a prospective case-control-control study the factors associated with a clinical sample positive for a NS-CARB isolate by distinguishing isolates non-CARBase-producing and isolates CARBase-producing.This study will be carried out during one year in 18 hospitals across France whose laboratory will participate in the prevalence study. The variables independently associated with a clinical sample positive for either a NS-CARB, non-CARBase-producing isolate or a NS-CARB, CARBase-producing isolate will be determined in a multivariate analysis.
Measured: 1 year
Secondary outcomes (2)
Detection of CARBase producing isolates as a measure of the diagnostic value of the phenotypic algorithm
Assessing the diagnostic value (sensitivity, specificity, positive predictive value and negative predictive value) of the phenotypic algorithm for the detection CARBase producing isolates by using the molecular methods as Gold standard method
Measured: 1 year
Impact of the use of the phenotypic algorithm on the management of the patients identified as carrier of NS-CARB isolate.
Assessing the impact of the use of the phenotypic algorithm on the management of the patients identified as carrier of NS-CARB isolate (case) in the 18 hospitals : (i) time between the period at which the isolate is identified as NS-CARB and, on the one hand, knowledge acquisition by the Hygiene team and the medical staff of the presence of the case, and on the other hand, the period at which barrier precautions are implemented by distinguishing the type of barrier precautions implemented (standard or with dedicated non-medical staff) (ii) the duration of the implementation of barrier precaution with regard to the results concerning the production or the non-production of a CARBase by the NS-CARB isolate . The results of this study will be compared with the results obtained during a previous study in which the phenotypic algorithm had not been used.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterobacteria Non Susceptible to Carbapenem CarrierStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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-control
- Time perspective
- Prospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Hélène Nicolas-Chanoine, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127450
- Sponsor's protocol ID
- NI 12025
- Acronym
- E-CARB
- Status last verified
- Nov 2016
- First submitted
- 16 Apr 2014
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
- ClinicalTrials.gov ID
- NCT02127450
- Acronym / sponsor ID
- E-CARB / NI 12025
- Conditions
- Enterobacteria Non Susceptible to Carbapenem Carrier, Enterobacteria Susceptible to Carbapenem Carrier
- Keywords
- Enterobacteriaceae, non-susceptible to carbapenem, carbapenemases, prevalence, screening algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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 non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in the routine in any laboratory is difficult. it will be useful to standardize them detection to control the emergence.
Detailed description
The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy because CARBA are often the alone antibiotics available to cure severe infections due to extended-spectrum β-lactamase (ESBL)-producing isolates. Two mechanisms of resistance to CARBA have been identified: membrane impermeability associated with ESBL or cephalosporinase production and carbapenemase (CARBase) production. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital in order to avoid the dissemination of the CARBase-producing strain and insure patient safety. Prevalence rate of non-susceptible (NS) isolates to CARB, the proportion of the two types of mechanisms of resistance to CARB and the factors associated with CARB- NS isolates are still unknown in France. Moreover, detecting CARBase in the routine in any laboratory is difficult. Providing data regarding all of these points will be useful for any hospital and will permit to optimize the management of the patients suspected or proved to harbor a CARBase-producing Enterobacteriaceae isolate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case: NS-CARB positive | – | –Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae |
| Control 1: non-NS-CARB positive | – | –Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae |
| Control 2 : negative sample | – | –Patient having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patient hospitalised for more than 24 hours , with a clinical sample positive for a NS-CARB Enterobacteriaceae * Patient hospitalised for more than 24 hours with clinical sample positive for a non-NS-CARB Enterobacteriaceae and hospitalised in the same type of ward as that case * Patient hospitalised for more than 24 hours having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case, hospitalised in any type of ward in the hospital
Key inclusion criteria (3 listed)
- Case: Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae
- Control 1: Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae and hospitalised in the same type of ward as that case
- Control 2: Patient having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case, hospitalised in any type of ward in the hospital
Key exclusion criteria (1 listed)
- the patient with digestive ER-CARB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of CARB-NS isolates and among them the proportion of those producing CARBase.
Time frame: 1 year
Determining the prevalence rate of CARB-NS isolates and among them the proportion of those producing CARBase for all enterobacterial species and for each species. CARBase production will be determined by using in a phenotypic algorithm previously established on the basis on commercialized tests and by molecular methods. Determining by using a prospective case-control-control study the factors associated with a clinical sample positive for a NS-CARB isolate by distinguishing isolates non-CARBase-producing and isolates CARBase-producing.This study will be carried out during one year in 18 hospitals across France whose laboratory will participate in the prevalence study. The variables independently associated with a clinical sample positive for either a NS-CARB, non-CARBase-producing isolate or a NS-CARB, CARBase-producing isolate will be determined in a multivariate analysis.
2 secondary outcomes
Detection of CARBase producing isolates as a measure of the diagnostic value of the phenotypic algorithm
Time frame: 1 year
Impact of the use of the phenotypic algorithm on the management of the patients identified as carrier of NS-CARB isolate.
Time frame: 1 year
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 28 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Marie-Hélène Nicolas-Chanoine, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterobacteria Non Susceptible to Carbapenem Carrier and Enterobacteria Susceptible to Carbapenem Carrier, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 3 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of CARB-NS isolates and among them the proportion of those producing CARBase. (time frame: 1 year). 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 28 Nov 2016.