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

Antibiotic Resistant Infection Clinical Trial

— AEGON  

Official title:

Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of Vancomycin-resistant Enterococcus Faecium (VREf) - A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624464
• Other study ID #: 19-1325
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: University Hospital of Cologne
• Contact: Annika Y. Claßen, Dr. med
• Phone: +49221 47897345
• Email: annika.classen[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Infection
• VRE Infection

Intervention

Other:
• Rectal swabs - microbiological analysis
Microbial analyses will be performed from the rectal swabs obtained.
• Examination of patient room
Only performed for cohort 2

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne	NRW

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of Cologne	Universitätsklinikum Hamburg-Eppendorf, University Hospital Lübeck, University of Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Biehl LM, Higgins P, Wille T, Peter K, Hamprecht A, Peter S, Dörfel D, Vogel W, Häfner H, Lemmen S, Panse J, Rohde H, Klupp EM, Schafhausen P, Imirzalioglu C, Falgenhauer L, Salmanton-García 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. — View Citation

Gastmeier P, Schröder 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. — View Citation

Liss BJ, Vehreschild JJ, Cornely OA, Hallek M, Fätkenheuer 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. — View Citation

Vehreschild MJGT, Haverkamp M, Biehl LM, Lemmen S, Fätkenheuer 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Standard culture VREf detection	Cohort 1: Quantitative detection limit of standard culture methods for VREf detection compared to enrichment culture and qPCR (quantitative polymerase chain reaction)	baseline and every week up to 10 weeks max.
Secondary	Antibiotics	Cohort 1: Identification of antibiotic classes that increase the risk of clonal expansion and subsequent domination by VREf. Domination by VREf is defined as the combination of cultural VREf detection from a sample and 16S rRNA (16S ribosomal ribonucleic acid) sequencing of the relative frequency of the Enterococcus genus over 30% as the most abundant genus in the sample.	baseline and every week up to 10 weeks max.
Secondary	Inadequately administered antibiotics	Cohort 1: Proportion of inadequately administered antibiotics, defined as unnecessary, too long, too broad or too high doses in patients who develop VREf domination (see definition above) compared to patients without VREf acquisition and patients with VREf acquisition but without domination.	baseline and every week up to 10 weeks max.
Secondary	Adequate antibiotic	Cohort 1: Rate of patients with no or adequate antibiotic therapy compared to patients with inadequate antibiotic therapy who develop a new colonization with VREf during the stay	baseline and every week up to 10 weeks max.
Secondary	Influence of antibiotic exposure duration	Cohort 1: Influence of antibiotic exposure duration on microbiota	baseline and every week up to 10 weeks max.
Secondary	Influence of antibiotic class	Cohort 1: Influence of antibiotic class on microbiota	baseline and every week up to 10 weeks max.
Secondary	VREf contamination	Cohort 2: Identification of high risk objects and surfaces for VREf contamination in patient rooms with known VREf-positive patients	baseline at least every 72 hours up to max of 20 days.
Secondary	Correlation of the antibiotic exposure	Cohort 2: Correlation of the antibiotic exposure of already known VREf-positive patients with the contamination load of objects and surfaces in the corresponding patient room.	baseline at least every 72 hours up to max of 20 days.
Secondary	Contamination load of objects	Cohort 2: Correlation of the relative proportion of enterococci in intestinal microbiota with the contamination load of objects and surfaces in the associated patient room	baseline at least every 72 hours up to max of 20 days.
Secondary	Cleaning quality	Cohort 2: Correlation of cleaning quality with the contamination load of VREf on objects and surfaces in rooms of known VRE-positive patients	baseline at least every 72 hours up to max of 20 days.