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

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.

Study Overview

• Status: Recruiting
• Conditions: MDRO
• Intervention / Treatment: Other: rectal swab

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

Study Locations

• Germany
  • Lübeck, Germany
    • Recruiting
    • Klinik für Infektiologie und Mikrobiologie
    • Contact: Nadja Käding; Phone Number: +4945131019010; Email: nadja.kaeding@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

For the prevalence, adult patients admitted to the hosptial within the last 3 days.

For BSI surveillance, adult inpatients with at least one blood culture positive for any of the target organisms: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa.

Description

Inclusion Criteria:

• at least 18 years old
• informed consent
• inpatient

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Luebeck
• Collaborators: University Hospital Tuebingen; University of Giessen; University Hospital Freiburg; University Hospital of Cologne; University Hospital of Berlin

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DZIF TTU 08.824

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No