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

University Hospital of Cologne

Status: Unknown

Conditions: Antibiotic Resistant Infection; VRE Infection

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

Study type: Observational

Funder types: Other

Identifiers

NCT04624464

19-1325

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

170 participants in 2 patient groups

Cohort 1: VRE negative at admission

Description:

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).

Treatment:

Other: Rectal swabs - microbiological analysis

Cohort 2: VRE positive at admission

Description:

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

Treatment:

Other: Rectal swabs - microbiological analysis

Other: Examination of patient room