Can a rapid screening strategy improve infection control in critically ill patients?
| ISRCTN | ISRCTN23588440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23588440 |
| Secondary identifying numbers | 2018-00329 |
- Submission date
- 31/01/2019
- Registration date
- 11/03/2019
- Last edited
- 05/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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?
From April 2019 to October 2020.
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).
Contact information
Scientific
Rue Gabrielle Perret-Gentil, 6
Geneva
1211
Switzerland
 ORCID ID |
0000-0002-3551-1025 |
|---|---|
| Phone | +41 (0)22 372 98 28 |
| stephan.harbarth@hcuge.ch |
Public
Rue Gabrielle Perret-Gentil, 6
Geneva
1211
Switzerland
| ORCID ID |
0000-0002-3551-1025 |
|---|---|
| Phone | +41 (0)22 372 98 28 |
| stephan.harbarth@hcuge.ch |
Study information
| Study design | Quasi-experimental study without control groups, non-randomised |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available. |
| 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 |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/01/2018 |
| Completion date | 31/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 101 patients with unneeded isolation measures in both periods. |
| Key inclusion criteria | All patients admitted to the Intensive Care Units during the study period |
| Key exclusion criteria | N/A |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 31/10/2020 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Geneva
1205
Switzerland
Sponsor information
University/education
Rue Gabrielle Perret-Gentil 4
(formerly 24 rue Micheli-du-Crest)
Geneva
1211
Switzerland
| Phone | +41 (0)22 372 91 34 |
|---|---|
| contact.crc@hcuge.ch | |
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/06/2022 | 08/06/2022 | Yes | No | |
| Protocol file | 05/09/2022 | 05/09/2022 | No | No |
Additional files
Editorial Notes
05/09/2022: Protocol file uploaded.
08/06/2022: Publication reference added.
15/03/2022: The intention to publish date was changed from 01/03/2022 to 01/05/2022.
13/12/2021: The intention to publish date was changed from 31/12/2021 to 01/03/2022.
02/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2021 to 31/10/2020.
2. The overall trial end date has been changed from 31/05/2021 to 31/10/2020 and the plain English summary has been updated to reflect this change.
07/02/2019: Trial’s existence confirmed by Cantonal Commission for Research Ethics (CCER).
