R-Net: Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network

Sponsor

University of Luebeck (Other)

Overall Status

Recruiting

CT.gov ID

NCT04937361

Collaborator

University Hospital of Berlin (Other), University Hospital of Cologne (Other), University Hospital Freiburg (Other), University of Giessen (Other), University Hospital Tuebingen (Other)

12,000

Enrollment

Location

48.2

Anticipated Duration (Months)

248.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Survey on the prevalence of MDRO to monitor the import of MDRO from the community. Rectal swabs will be taken and cultivated. Survey on community-onset and nosocomial bloodstream infections will be documented and strains will be isolated. For each BSI a clinical data set will be obtained (e.g. patient age, gender, date of hospitalization, antibiotic therapy). Genetic analysis of MDRO from the prevalence and BSI study. In a subset of patients the microbiome-resistome interactome will be analysed in more detail. Furthermore, the impact of infection control measures due to the Covid-19 pandemic on nosocomial BSI will be investigated.

Condition or Disease	Intervention/Treatment	Phase
MDRO	Other: rectal swab

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

12000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network

Actual Study Start Date :

Jun 23, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Outcome Measures

Primary Outcome Measures

monitoring of MDRO prevalence [at hospital admission]
obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure
monitoring of blood stream infections [during hospitalization, up to 4 weeks]
obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure
integrate novel techniques for microbiome-resistome interaction analysis [through study completion, after 4 years]
obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

at least 18 years old
informed consent
inpatient

Exclusion Criteria:

less than 18 years old
Not capable of giving informed consent
outpatient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Infektiologie und Mikrobiologie	Lübeck		Germany

Sponsors and Collaborators

University of Luebeck
University Hospital of Berlin
University Hospital of Cologne
University Hospital Freiburg
University of Giessen
University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nadja Käding, Dr. med., University of Luebeck

ClinicalTrials.gov Identifier:

NCT04937361

Other Study ID Numbers:

DZIF TTU 08.824

First Posted:

Jun 24, 2021

Last Update Posted:

Sep 29, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 29, 2021