Clinical trial NCT04624464: Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of VRE
Official title: Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of Vancomycin-resistant Enterococcus Faecium (VREf) - A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: VRE Infection
Antibiotic Resistant Infection
Keywords: VRE
Infection Control Measures
Antimicrobial Stewardship
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
Collaborators: name: University of Freiburg
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital Lübeck
First posted: 2020-11-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Part 1

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).

Primary outcomes:
measure: VREf - Intestinal microbiota
timeFrame: Baseline
measure: VREf - Patient rooms
timeFrame: Change from baseline spread to spread at 10 weeks.
Secondary outcomes:
measure: Standard culture VREf detection
timeFrame: baseline and every week up to 10 weeks max.
measure: Antibiotics
timeFrame: baseline and every week up to 10 weeks max.
measure: Inadequately administered antibiotics
timeFrame: baseline and every week up to 10 weeks max.
measure: Adequate antibiotic
timeFrame: baseline and every week up to 10 weeks max.
measure: Influence of antibiotic exposure duration
timeFrame: baseline and every week up to 10 weeks max.
measure: Influence of antibiotic class
timeFrame: baseline and every week up to 10 weeks max.
measure: VREf contamination
timeFrame: baseline at least every 72 hours up to max of 20 days.
measure: Correlation of the antibiotic exposure
timeFrame: baseline at least every 72 hours up to max of 20 days.
measure: Contamination load of objects
timeFrame: baseline at least every 72 hours up to max of 20 days.
measure: Cleaning quality
timeFrame: baseline at least every 72 hours up to max of 20 days.
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: University Hospital of Cologne
name: Jörg Janne Vehreschild, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Cologne
name: Maria J.G.T. Vehreschild, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.