Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of VRE

NCT ID: NCT04624464

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-31

Brief Summary

The AEGON study is a German multicenter, prospective observational study. The study consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VREf-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board (Antimicrobial Stewardship Board). In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure.

Detailed Description

Current studies show that Vancomycin-resistant Enterococci (VRE) have become increasingly widespread throughout Germany in recent years, especially E. faecium (VREf). Healthy individuals can come into contact with VREf in various ways, for example via the food chain, contaminated drinking water or animal contacts. A possibly caused low-grade colonisation of the gastrointestinal tract with VREf (so-called low-level colonisation) can remain undetected during hospital admission using routine screening methods. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.

The study is a German multicenter, prospective observational study and consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VRE-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board. In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.

Conditions

VRE Infection; Antibiotic Resistant Infection

Keywords

VRE; Infection Control Measures; Antimicrobial Stewardship

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1: VRE negative at admission

150 patients meeting the following inclusion criteria:

• ≥ 18 years
• Patients with malignant primary disease and current inpatient admission to a normal ward with expected inpatient stay of at least 15 days
• High risk of exposure to antibiotics during the stay
• Written informed consent of the patient after clarification has been given

Exclusion criteria:

• Already known current or documented past colonisation or infection by VRE
• Simultaneous participation in other studies is only an exclusion criterion if the other study explicitly excludes participation in observational studies or if the other study complicates the interpretation of the endpoints of AEGON (e.g. double-blind study on antibiotic use).

Rectal swabs - microbiological analysis

Intervention Type: OTHER

Microbial analyses will be performed from the rectal swabs obtained.

Cohort 2: VRE positive at admission

A total 20 known VREf-positive patients meeting the following inclusion criteria:

• Intestinal VREf colonization already known at the time of admission (e.g. based on examinations during previous stays or in external facilities)
• Accommodation in a single room or alternatively multi-bed room with single occupancy on standard wards
• Expected stay of at least 7 days

Rectal swabs - microbiological analysis

Intervention Type: OTHER

Microbial analyses will be performed from the rectal swabs obtained.

Examination of patient room

Intervention Type: OTHER

Only performed for cohort 2

Interventions

Rectal swabs - microbiological analysis

Microbial analyses will be performed from the rectal swabs obtained.

Intervention Type: OTHER

Examination of patient room

Only performed for cohort 2

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years
• Patients with malignant primary disease and current inpatient admission to a normal ward with expected inpatient stay of at least 15 days
• High risk of exposure to antibiotics during the stay
• Written informed consent of the patient after clarification has been given

Exclusion Criteria

• Already known current or documented past colonisation or infection by VRE
• Simultaneous participation in other studies is only an exclusion criterion if the other study explicitly excludes participation in observational studies or if the other study complicates the interpretation of the endpoints of AEGON (e.g. double-blind study on antibiotic use).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Freiburg

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University Hospital Lübeck

OTHER

Sponsor Role: collaborator

University Hospital of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Jörg Janne Vehreschild

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jörg Janne Vehreschild, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

Maria J.G.T. Vehreschild, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

Locations

University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Annika Y. Claßen, Dr. med

Role: CONTACT

Phone: +49221 47897345

Email: annika.classen@uk-koeln.de

Lena M. Biehl, Dr. med

Role: CONTACT

Phone: +49221 4781425649

Email: lena.biehl@uk-koeln.de

Facility Contacts

Jörg Janne Vehreschild, MD

Role: primary

References

Gastmeier P, Schroder C, Behnke M, Meyer E, Geffers C. Dramatic increase in vancomycin-resistant enterococci in Germany. J Antimicrob Chemother. 2014 Jun;69(6):1660-4. doi: 10.1093/jac/dku035. Epub 2014 Mar 9.

Reference Type: BACKGROUND

PMID: 24615816 (View on PubMed)

Liss BJ, Vehreschild JJ, Cornely OA, Hallek M, Fatkenheuer G, Wisplinghoff H, Seifert H, Vehreschild MJ. Intestinal colonisation and blood stream infections due to vancomycin-resistant enterococci (VRE) and extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBLE) in patients with haematological and oncological malignancies. Infection. 2012 Dec;40(6):613-9. doi: 10.1007/s15010-012-0269-y. Epub 2012 Jun 5.

Reference Type: BACKGROUND

PMID: 22665143 (View on PubMed)

Vehreschild MJGT, Haverkamp M, Biehl LM, Lemmen S, Fatkenheuer G. Vancomycin-resistant enterococci (VRE): a reason to isolate? Infection. 2019 Feb;47(1):7-11. doi: 10.1007/s15010-018-1202-9. Epub 2018 Sep 3.

Reference Type: BACKGROUND

PMID: 30178076 (View on PubMed)

Biehl LM, Higgins P, Wille T, Peter K, Hamprecht A, Peter S, Dorfel D, Vogel W, Hafner H, Lemmen S, Panse J, Rohde H, Klupp EM, Schafhausen P, Imirzalioglu C, Falgenhauer L, Salmanton-Garcia J, Stecher M, Vehreschild JJ, Seifert H, Vehreschild MJGT. Impact of single-room contact precautions on hospital-acquisition and transmission of multidrug-resistant Escherichia coli: a prospective multicentre cohort study in haematological and oncological wards. Clin Microbiol Infect. 2019 Aug;25(8):1013-1020. doi: 10.1016/j.cmi.2018.12.029. Epub 2019 Jan 12.

Reference Type: BACKGROUND

PMID: 30641228 (View on PubMed)

Other Identifiers

19-1325

Identifier Type: -

Identifier Source: org_study_id