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

NCT04624464 | Unknown

• 1 other identifier: 19-1325
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

VRE Infection; Antibiotic Resistant Infection

Keywords

VRE; Infection Control Measures; Antimicrobial Stewardship

Outcome Measures

Primary Outcomes (2)

• VREf - Intestinal microbiota

  Primary Outcome for Cohort 1: Rate of VREf intestinal colonization detected by enrichment culture or specific PCR at time of uptake not detected by standard culture methods

  Baseline

• VREf - Patient rooms

  Primary Outcome for Cohort 2: Description of the spread of VREf in single rooms newly enrolled in known VREf-positive patients

  Change from baseline spread to spread at 10 weeks.

Secondary Outcomes (10)

• Standard culture VREf detection

  baseline and every week up to 10 weeks max.

• Antibiotics

  baseline and every week up to 10 weeks max.

• Inadequately administered antibiotics

  baseline and every week up to 10 weeks max.

• Adequate antibiotic

  baseline and every week up to 10 weeks max.

• Influence of antibiotic exposure duration

  baseline and every week up to 10 weeks max.

Study Arms (2)

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).

Other: Rectal swabs - microbiological analysis

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

Other: Rectal swabs - microbiological analysis; Other: Examination of patient room

Interventions

Rectal swabs - microbiological analysis OTHER

Microbial analyses will be performed from the rectal swabs obtained.

Cohort 1: VRE negative at admission; Cohort 2: VRE positive at admission

Examination of patient room OTHER

Only performed for cohort 2

Cohort 2: VRE positive at admission

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

The selection of patients to be included in Part 1 of the AEGON study is based on the risk stratification for the nosocomial acquisition of VREf performed in the CONTROL study. It is planned to include a total of 150 patients from the participating study centers in Part 1. Based on the results of the CONTROL study, it can be assumed that within the selected target group in approx. 11% there is already an VREf colonisation by direct culture at admission and in 15% of the cases (22 of 150 patients) a nosocomial acquisition of VREf by direct culture (see method part) can be determined. Patients with VREcolonization detected at admission are excluded from the study.

You may qualify if:

• ≥ 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

You may not qualify if:

• Already known current or documented past colonisation or infection by VRE

Sponsors & Collaborators

• University Hospital of Cologne: lead
• University of Freiburg: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital Lübeck: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 24615816 BACKGROUND

• 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.

  PMID: 22665143 BACKGROUND

• 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.

  PMID: 30178076 BACKGROUND

• 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.

  PMID: 30641228 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cohort 1 (VRE negative at inclusion) and 2 (VRE positive at inclusion): Collection of rectal swabs for further microbiological analysis

Study Officials

• Jörg Janne Vehreschild, Prof. Dr. med

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

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

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Y. Claßen, Dr. med

CONTACT

+49221 47897345; annika.classen@uk-koeln.de

Lena M. Biehl, Dr. med

CONTACT

+49221 4781425649; lena.biehl@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: November 10, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

DE (1)