Carbapenemase-producing Enterobacteriaceae InfectionsOPTIM-BHReNCT05272410
Cost-effectiveness of Controlling CPE
An observational study of Carbapenemase-producing Enterobacteriaceae Infections, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Spread of extensively drug-resistant bacteria (XDR) such as carbapenemase-producing Enterobacterales (CPE) is a major public health problem. Various prevention and control interventions are implemented to limit the transmission of XDR but they are expensive and often disrupt hospital organization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenemase-producing Enterobacteriaceae Infections
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Sep 2023
- 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: The study is based on numerical simulations and data collected from APHP hospitals. We will model the transmission of CPEs and the interventions implemented against these bacteria in a 25-bed non-intensive care unit. Transmission between patients is considered to occur through caregivers, nurses and orderlies. We will conduct a case-control study in patients colonized or infected with CEP, hospitalized at APHP hospitals between January and June 2019.
Who may be able to join
- patients infected with emerging highly resistant bacteria at acute care hospital.
Who cannot join
- patients infected while hospitalized in intensive care unit.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cost-effectiveness of Strategies to Control the Spread of Carbapenemase-producing Enterobacteriaceae (CPE) in Hospitals
Spread of extensively drug-resistant bacteria (XDR) such as carbapenemase-producing Enterobacterales (CPE) is a major public health problem. Various prevention and control interventions are implemented to limit the transmission of XDR but they are expensive and often disrupt hospital organization. In this study, a mathematical model will be used to study the effectiveness and cost-effectiveness of control strategies to limit the spread of CPE in a general hospital ward. A case-control study will be conducted to estimate the excess length of stay and mortality attributable to CPE colonisation or infection.
Read the detailed description
Carbapenemase-producing Enterobacterales (CPE) are increasingly common in hospitals and represent a serious health problem. These multidrug-resistant organisms colonise the gastrointestinal tract after direct (person-to-person) or indirect (via contaminated surfaces) transmission and are a common cause of urinary tract infections, ventilator-associated pneumonia and bloodstream infections in healthcare settings. Treatment options for patients infected with CPE are limited leading to high mortality, increased length of hospital stay and hospital costs. The successful implementation of cost-effective infection control measures to prevent CPE spread and infections is key for infection control preventionists and hospital managers.
Recommendations to limit the transmission of CPE in healthcare facilities are based on the early detection of asymptomatic carriers, implementation of contact precautions and isolation in single room. In practice, strategies combining various interventions are employed according to the risk assessment and available resources: 1) universal or targeted rectal screening on admission, 2) standard precautions (SP), applied to all patients regardless of their infectious status, 3) contact precautions (CP) for identified carriers or infected patients, 4) isolation in a single room, 5) environmental cleaning, 6) rectal screening of contact patients, i.e. those whose care was provided by the same team as the CPE patient, and/or 7) isolation of carriers in a dedicated area with dedicated nursing staff (DNS), thereafter designated as cohorting.
However, these control measures pose challenges such as the high cost of patient's screening and cohorting, requirement for single room isolation or staff shortage for implementing precautions. Moreover, the effectiveness and cost-effectiveness of various CPE control strategies is under-documented.
OBJECTIVES:
Primary:
To evaluate the cost-effectiveness of different strategies combining screening and contact precaution measures to control the spread of CPE in a general medicine ward (GW) using a mathematical model.
Secondary:
- To assess the impact of CPE colonisation/ infection on patient's outcome (mortality, length of stay)
- To analyse the resources used to manage CPE cases
- To analyse the care pathway of a CPE case and study whether carrying the CPE represents the opportunity loss for the patient,
METHODS AND TOOLS:
A dynamic, stochastic model simulates the transmission of CPE by the hands of healthcare workers (HCWs) and the environment in a hypothetical GW. Input parameters are based on data from APHP hospitals and from the literature.
12 strategies are compared to the baseline (no control) and combined different prevention and control interventions: targeted or universal screening at admission (TS or US), contact precautions (CP), isolation in a single room, dedicated nursing staff (DNS) for carriers and weekly screening of contact patients (WS). Time horizon is one year.
A hospital perspective is adopted to estimate costs, which included laboratory costs, single room, contact precautions, staff time, i.e. infection control nurse and/or nurses for cohorting, and lost bed-days due to prolonged hospital stay of identified carriers.
A case-control study will be conducted to assess the impact of CPE colonization / infection on patient's outcomes. Cases will be the patients newly identified as CPE colonized or infected during the first semester 2016 in the APHP hospital network, i.e. around 450 cases. In the case of hospital CPE outbreak, index and secondary cases will be included. Cases will be followed until discharge from the hospital setting, including rehabilitation or home care. Since all discharges in France, either from public or private HCFs, are registered in the single national hospital discharge database PMSI (HDD), it is possible to link all hospital stays and retrieve the entire hospital course.
Controls will be selected in the national HDD on a 1:1 ratio, based on the following matching criteria: absence of known colonization with CPE, age, gender, hospital stay in the same unit as the corresponding case during the 1st semester 2016, same DRG and duration of hospital stays at least as long at the time to colonization in the case.
The following information will be collected in cases and controls:
- demographic data, country of born (and if so date of entry in France),
- Charlson comorbidity score, McCabe score, activity of daily living (ADL) score at discharge from the index hospital stay,
- main and secondary DRG in the HDD system,
- socioeconomic status, estimated by the address of living (IRIS score), type of registration in the national insurance security,
- origin at hospital admission, whether the case is an index or secondary CPE colonized/infected,
- whether the case was only colonized or infected, type of Enterobacteriaceae carrying the resistance gene, and type of resistance gene
- control measures implemented for controlling the episode: contact precautions, reinforced personnel, dedicated personnel, interruption of admission and transfers
- activity of the unit of first admission: number of bed, yearly number of admissions and hospital days A cost-effectiveness analysis will be undertaken to find the most favourable control strategies from the model simulations. Sensitivity analysis will identify the factors that have the greatest impact on the results.
- Keywords
- CPE spread, CPE infections, CPE deaths
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 |
|---|---|---|
| cases | Patients colonized or infected with CPE | |
| controls | Patients not colonized or infected with CPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICER- the ratio of the difference in costs to difference in health benefits
The incremental cost-effectiveness ratios (ICER) calculated as the extra annual cost of one strategy relative to another divided by CPE cases avoided by that strategy relative to the other strategy
Measured: 12 months
Secondary outcomes (7)
Number of CPE acquisitions
Number of CPE acquisitions observed for each strategy simulated in the model
Measured: 6 months after the end of the data collection
Costs of strategies
Description: costs associated with each strategy (e.g. laboratory costs, cost of single room, contact precautions, staff time)
Measured: 6 months after the end of the data collection
Number of days when hospital admissions interrupted
Number of days when the presence of EPC in a ward leads to the interruption of new admissions
Measured: 6 months after the end of the data collection
Number of days when hospital transfers interrupted
Description: Number of days when the presence of EPC in a ward leads to the interruption of transfers
Measured: 6 months after the end of the data collection
frequency of employment of dedicated staff
% of situations where dedicated staff were employed for the management of CPE cases
Measured: 6 months after the end of the data collection
length of hospital stay of patients
length of hospital stay for cases (CPE infected or colonised patients) and controls
Measured: 6 months after the end of the data collection
risk of death
risk of in-hospital death for cases (CPE infected or colonised patients) and controls
Measured: 6 months after the end of the data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenemase-producing Enterobacteriaceae InfectionsStudies 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
- Retrospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272410
- Sponsor's protocol ID
- OPTIM BHRe
- Acronym
- OPTIM-BHRe
- Status last verified
- Jul 2021
- First submitted
- 25 Nov 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Strategies to Control the Spread of Carbapenemase-producing Enterobacteriaceae (CPE) in Hospitals
- ClinicalTrials.gov ID
- NCT05272410
- Acronym / sponsor ID
- OPTIM-BHRe / OPTIM BHRe
- Keywords
- CPE spread, CPE infections, CPE deaths
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 9 Mar 2022 (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.
Spread of extensively drug-resistant bacteria (XDR) such as carbapenemase-producing Enterobacterales (CPE) is a major public health problem. Various prevention and control interventions are implemented to limit the transmission of XDR but they are expensive and often disrupt hospital organization. In this study, a mathematical model will be used to study the effectiveness and cost-effectiveness of control strategies to limit the spread of CPE in a general hospital ward. A case-control study will be conducted to estimate the excess length of stay and mortality attributable to CPE colonisation or infection.
Detailed description
Carbapenemase-producing Enterobacterales (CPE) are increasingly common in hospitals and represent a serious health problem. These multidrug-resistant organisms colonise the gastrointestinal tract after direct (person-to-person) or indirect (via contaminated surfaces) transmission and are a common cause of urinary tract infections, ventilator-associated pneumonia and bloodstream infections in healthcare settings. Treatment options for patients infected with CPE are limited leading to high mortality, increased length of hospital stay and hospital costs. The successful implementation of cost-effective infection control measures to prevent CPE spread and infections is key for infection control preventionists and hospital managers.
Recommendations to limit the transmission of CPE in healthcare facilities are based on the early detection of asymptomatic carriers, implementation of contact precautions and isolation in single room. In practice, strategies combining various interventions are employed according to the risk assessment and available resources: 1) universal or targeted rectal screening on admission, 2) standard precautions (SP), applied to all patients regardless of their infectious status, 3) contact precautions (CP) for identified carriers or infected patients, 4) isolation in a single room, 5) environmental cleaning, 6) rectal screening of contact patients, i.e. those whose care was provided by the same team as the CPE patient, and/or 7) isolation of carriers in a dedicated area with dedicated nursing staff (DNS), thereafter designated as cohorting.
However, these control measures pose challenges such as the high cost of patient's screening and cohorting, requirement for single room isolation or staff shortage for implementing precautions. Moreover, the effectiveness and cost-effectiveness of various CPE control strategies is under-documented.
OBJECTIVES:
Primary:
To evaluate the cost-effectiveness of different strategies combining screening and contact precaution measures to control the spread of CPE in a general medicine ward (GW) using a mathematical model.
Secondary:
- To assess the impact of CPE colonisation/ infection on patient's outcome (mortality, length of stay)
- To analyse the resources used to manage CPE cases
- To analyse the care pathway of a CPE case and study whether carrying the CPE represents the opportunity loss for the patient,
METHODS AND TOOLS:
A dynamic, stochastic model simulates the transmission of CPE by the hands of healthcare workers (HCWs) and the environment in a hypothetical GW. Input parameters are based on data from APHP hospitals and from the literature.
12 strategies are compared to the baseline (no control) and combined different prevention and control interventions: targeted or universal screening at admission (TS or US), contact precautions (CP), isolation in a single room, dedicated nursing staff (DNS) for carriers and weekly screening of contact patients (WS). Time horizon is one year.
A hospital perspective is adopted to estimate costs, which included laboratory costs, single room, contact precautions, staff time, i.e. infection control nurse and/or nurses for cohorting, and lost bed-days due to prolonged hospital stay of identified carriers.
A case-control study will be conducted to assess the impact of CPE colonization / infection on patient's outcomes. Cases will be the patients newly identified as CPE colonized or infected during the first semester 2016 in the APHP hospital network, i.e. around 450 cases. In the case of hospital CPE outbreak, index and secondary cases will be included. Cases will be followed until discharge from the hospital setting, including rehabilitation or home care. Since all discharges in France, either from public or private HCFs, are registered in the single national hospital discharge database PMSI (HDD), it is possible to link all hospital stays and retrieve the entire hospital course.
Controls will be selected in the national HDD on a 1:1 ratio, based on the following matching criteria: absence of known colonization with CPE, age, gender, hospital stay in the same unit as the corresponding case during the 1st semester 2016, same DRG and duration of hospital stays at least as long at the time to colonization in the case.
The following information will be collected in cases and controls:
- demographic data, country of born (and if so date of entry in France),
- Charlson comorbidity score, McCabe score, activity of daily living (ADL) score at discharge from the index hospital stay,
- main and secondary DRG in the HDD system,
- socioeconomic status, estimated by the address of living (IRIS score), type of registration in the national insurance security,
- origin at hospital admission, whether the case is an index or secondary CPE colonized/infected,
- whether the case was only colonized or infected, type of Enterobacteriaceae carrying the resistance gene, and type of resistance gene
- control measures implemented for controlling the episode: contact precautions, reinforced personnel, dedicated personnel, interruption of admission and transfers
- activity of the unit of first admission: number of bed, yearly number of admissions and hospital days A cost-effectiveness analysis will be undertaken to find the most favourable control strategies from the model simulations. Sensitivity analysis will identify the factors that have the greatest impact on the results.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –Patients colonized or infected with CPE |
| controls | – | –Patients not colonized or infected with CPE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is based on numerical simulations and data collected from APHP hospitals. We will model the transmission of CPEs and the interventions implemented against these bacteria in a 25-bed non-intensive care unit. Transmission between patients is considered to occur through caregivers, nurses and orderlies. We will conduct a case-control study in patients colonized or infected with CEP, hospitalized at APHP hospitals between January and June 2019.
Key inclusion criteria (1 listed)
- patients infected with emerging highly resistant bacteria at acute care hospital.
Key exclusion criteria (1 listed)
- patients infected while hospitalized in intensive care unit.
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
ICER- the ratio of the difference in costs to difference in health benefits
Time frame: 12 months
The incremental cost-effectiveness ratios (ICER) calculated as the extra annual cost of one strategy relative to another divided by CPE cases avoided by that strategy relative to the other strategy
7 secondary outcomes
Number of CPE acquisitions
Time frame: 6 months after the end of the data collection
Costs of strategies
Time frame: 6 months after the end of the data collection
Number of days when hospital admissions interrupted
Time frame: 6 months after the end of the data collection
Number of days when hospital transfers interrupted
Time frame: 6 months after the end of the data collection
frequency of employment of dedicated staff
Time frame: 6 months after the end of the data collection
length of hospital stay of patients
Time frame: 6 months after the end of the data collection
risk of death
Time frame: 6 months after the end of the data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbapenemase-producing Enterobacteriaceae Infections, run by Assistance Publique - Hôpitaux de Paris.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Christophe Pr Lucet, Professor (+33 140 256 194, jean-christophe.lucet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICER- the ratio of the difference in costs to difference in health benefits (time frame: 12 months). 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 9 Mar 2022.