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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Jean Christophe Pr Lucet, Professor contact

+33 140 256 194

jean-christophe.lucet@aphp.fr

Isabelle Pr Durand-Zaleski, Professor contact

+33 140 274 143

isabelle.durand-zaleski@aphp.fr

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 groups in NCT05272410
Study groupRoleWhat they receive
casesPatients colonized or infected with CPE
controlsPatients not colonized or infected with CPE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted9 Mar 2022
  2. Study startMar 2022 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

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)
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

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.

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