Condition category
Infections and Infestations
Date applied
31/01/2019
Date assigned
11/03/2019
Last edited
11/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Current microbiologic culture methods have proved to be slow and cumbersome to support the early and adequate implementation of standard precautions and contact precautions for critically ill patients colonized with multiresistant bacteria. This study aims to compare the effectiveness of a rapid screening strategy composed of a “Loop-mediated isothermal AMPlification” (LAMP) assay targeting the main multiresistant bacteria, with the currently used routine diagnostic method to implement early, adequate and individualized preventive measures in the critical care setting.

Who can participate?
This study will include all patients admitted in the Critical Care Units of Geneva University Hospitals from April 2019 to May 2021.

What does the study involve?
The study will add a novel screening strategy to cultures currently used in the surveillance program of resistant bacteria (ESBL and CPE). The addition of these screening methods aims to accelerate this surveillance and thereby the implementation or discontinuation of contact precautions.

What are the possible benefits and risks of participating?
Expected benefits from this study are a faster implementation of contact precaution when new carriers are detected during the weekly screening, and faster discontinuation of pre-emptive contact precautions when high-risk patients are negative during the targeted screening.

Where is the study run from?
The study run from Geneva University Hospitals

When is the study starting and how long is it expected to run for?
The study will start from April 2019 and will last 26 months, to May 2021.

Who is funding the study?
This study is funded by the Swiss National Science Foundation.

Who is the main contact?
The main contact and principal investigator is Dr. Stephan Harbarth (stephan.harbarth@hcuge.ch).

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephan Harbarth

ORCID ID

http://orcid.org/0000-0002-3551-1025

Contact details

Rue Gabrielle Perret-Gentil
6
Geneva
1211
Switzerland
+41 (0)22 372 98 28
stephan.harbarth@hcuge.ch

Type

Public

Additional contact

Prof Stephan Harbarth

ORCID ID

http://orcid.org/0000-0002-3551-1025

Contact details

Rue Gabrielle Perret-Gentil
6
Geneva
1211
Switzerland
+41 (0)22 372 98 28
stephan.harbarth@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2018-00329

Study information

Scientific title

A quasi-experimental interventional study to evaluate the impact of a rapid screening strategy in improving nosocomial ESBL and CPE control in critically ill patients

Acronym

Study hypothesis

A rapid screening strategy based a “Loop-mediated isothermal AMPlification” (LAMP) assay targeting the main ESBL-PE/CPE accelerates the implementation of adequate and individualized preventive measures in the critical care setting, compared to the currently used routine diagnostic methods.

Ethics approval

In agreement with the president of the Ethics Committee Geneva (8, Rue Adrien Lachenal, 1207 Geneva; +41 (0) 22 546 51 01; ccer@etat.ge.ch), the study design will be modified for a quasi-experimental study without cross-over as a quality improvement project that does not require informed consent, nor ethical approval.

Study design

Quasi-experimental study without control groups, non-randomised

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

No participant information sheet available.

Condition

Infection by ESBL or CPE bacteria

Intervention

This quasi-experimental study will alternate two 12-months intervention and control periods, and a 2-months wash-out period in-between. During the intervention period, a novel ESBL/CPE screening strategy will be processed in parallel of conventional methods, during the surveillance program established in the ICU routine to support ESBL and CPE control. The novel ESBL/CPE screening strategy will include the Loop-Mediated Isothermal Amplification (LAMP) eazyplex SuperBug CRE assay (AxonLab, UK), a qualitative genotypic test covering ESBLs and carbapenemases of the CTX M-1 and CTX M-9 families, VIM, NDM, KPC families, and OXA-48 (-48, -181). Visualization of results is provided in this assay through real-time fluorescence measurement of a fluorescent dye bound to double stranded DNA using the GENIE® II instrument. As a basis, the LAMP technology has already proved to be robust, cost-effective, real time, and performant for detecting ESBLs and carbapenemases on screening isolates. No follow-up is planned in this interventional study.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Unnecessary pre-emptive isolation-days will be determined using Turn-Around-Times for ESBL/CPE screening and work up, with the help of computerized laboratory databases and a specific tool integrated into the electronic patient file, informed in real time by patient dedicated nurses. This outcome will be measured for all high-risk patient with a negative result for ESBL and CPE on a targeted screening at admission, at the time of discontinuation of pre-emptive isolation.

Secondary outcome measures

1. Time between patient screening and implementation of contact precaution of previously unknown ESBL-PE and CPE carriers will be determined using Turn-Around-Times for ESBL/CPE screening and work up, with the help of computerized laboratory databases and a specific tool integrated into the electronic patient file, informed in real time by patient dedicated nurses. This outcome will be measured for all patients newly positive for ESBL and CPE on a weekly screening, at the time of implementation of contact precaution.
2. Adjusted incidence-density ratio of nosocomial ESBL/CPE acquisition will be determined using surveillance data prospectively collected by infection control nurses. This outcome will be measured monthly.

Overall trial start date

01/01/2018

Overall trial end date

31/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All patients admitted to the Intensive Care Units during the study period

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

101 patients with unneeded isolation measures in both periods.

Participant exclusion criteria

N/A

Recruitment start date

01/04/2019

Recruitment end date

31/05/2021

Locations

Countries of recruitment

Switzerland

Trial participating centre

Geneva University Hospitals
Rue Gabrielle-Perret-Gentil 4, 1205 Genève
Geneva
1205
Switzerland

Sponsor information

Organisation

Hôpitaux Universitaires de Genève

Sponsor details

Rue Gabrielle Perret-Gentil 4
(formerly 24 rue Micheli-du-Crest)
Geneva
1211
Switzerland
+41 (0)22 372 91 34
contact.crc@hcuge.ch

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

Dissemination of this interventional study will be primarily achieved by a publication in a peer-reviewed journal, in December 2021. The study results will also be presented at IPC conferences.

IPD sharing statement: the datasets generated during and analysed during the current study, as well as the "R code" used for analysis will be available upon request from Stephan Harbarth (stephan.harbarth@hcuge.ch). These data will be available during 3 years, in excel forms after anonymisation and "R scripts", from the 31.05.19, to the 31.05.2022. Anonymization will be achieved by the destruction of the code (separate Excel file). Without this code, the data stored cannot be crossed to identify any patient and are thus considered as anonymized. As data will be anonymized, consent is not required from patients. These Excel forms will be provided by mail.

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/02/2019: Trial’s existence confirmed by Cantonal Commission for Research Ethics (CCER).