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

NCT04937361 | Completed

• 1 other identifier: DZIF TTU 08.824
• Study Type: observational
• Target: 14,607
• Locations: 1 country
• Sites: 1

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.

Conditions

MDRO

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

rectal swab OTHER

collection of rectal swabs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• at least 18 years old
• informed consent
• inpatient

You may not qualify if:

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

Sponsors & Collaborators

• University of Luebeck: lead
• University Hospital of Berlin: collaborator
• University Hospital Tuebingen: collaborator
• University Hospital of Cologne: collaborator
• University Hospital Freiburg: collaborator
• University of Giessen: collaborator

Study Sites (1)

Klinik für Infektiologie und Mikrobiologie

Lübeck, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial strains isolated from rectal swabs, blood cultures and samples derived thereof (such as purified DNA)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 24, 2021
• Study Start: June 23, 2021
• Primary Completion: February 28, 2025
• Study Completion: May 31, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

DE (1)