Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient

NCT ID: NCT06370299

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-30

Brief Summary

The goal of this observational study is to evaluate the screening for multidrug resistant bacteria in patients admitted to hospitals in Scania. The main questions it aims to answer are:

• admission rates after screening
• 30-day and one-year mortality after screening Participants will be evaluated for positive screening results with following multidrug resistant gram negative bacilli: ESBL producing Enterobacterales, Carbapenemase producing Enterobacterales, Carbapenem resistant P.aeruginosa and carbapenem resistant Acinetobacter baumannii. Researchers will compare patients with positive and negative screening results to see, if the relative risks in the two groups differ in admission rates and mortality.

Detailed Description

Infections with multidrug resistant bacteria (MDR) cause more than one millions deaths globally according to World Health Organisation. While Scandinavia is still a low-endemic area of resistance compared to other parts of the world, such as South-Asia, South-Europe, a worrisome rise in MDR has been observed in the past decade. Of concern is particularly gram negative bacilli, e.g extended spectrum beta-lactamase (ESBL) and carbapenemase producing Enterobacterales (EPE and CPE) as well as carbapenem resistant Pseudomonas aeruginosa (CRPA) and Acinetobacter baumannii (CRAB). They can cause extremely 'difficult-to-treat' infections, while concomitantly give rise to outbreaks following dissemination in hospital settings for years. Hence patients with risk factors such as contact with health care systems outside of Scandinavia are routinely submitted to MDR screening on admission to hospitals in Scania in Sweden. Resource demanding isolation measures are upheld until negative screening results are reported.

The aim of this study is to evaluate our MDR screening in terms of the clinical course of patients with positive and negative screenings results, respectively.

Primary objective: to compare patients with positive screening results and patients with negative screening results regarding

1. admission rate within a year of screening;

2. occurrence rate of other MDR in clinical samples at the time of screening;

3. 30-day mortality and one-year mortality.

Secondary objective:

1. To evaluate the prevalence of positive screening results;

2. To characterize the MDR species and their phenotypical and genotypical resistance mechanisms;

3. To evaluate prevalence of MDR in clinical samples and time to first occurrence of phenotypically same MDR;

4. To evaluate prevalence of MDR in clinical samples within 30 days in patients with negative screening results.

For relevant primary and secondary outcomes, risk stratifications are performed for total, species and resistance mechanisms.

Methods Study design: population based observational cohort study.

Screening samples are defined as samples collected for purpose of infection prevention and control, and sent for targeted analysis of EPE, CPE, CRPA and CRAB. Following locations are typically screened: rectum/faeces, urine and risk factors such as indwelling catheters, drainage material and wound. Clinical samples are defined as all samples sent for culturing, inherently presumed for suspected infection. Isolates in clinical samples are determined as same as in screening, if they have phenotypically identical susceptibility.

Data collection: All patients included in screening (with negative and positive results) are identified through search in database (LIMS and wwBakt) at Department of Clinical Microbiology, Scania region. Social security numbers are thereafter linked to Regional Patient Register (Informationsplattformen) to collect information on comorbidities, hospital admissions, length of stay, death, antibiotics dispensed in outpatient care in general and specialised practices two weeks prior screening and up till one year after. Antibiotics during inpatient care is also collected. No medical journals will be investigated.

Condition of investigation: patients with positive screening results with following multidrug resistant gram negative bacilli: EPE, CPE, CRPA and CRAB.

"Unexposed" group consists of patients with comparable MDR risk factors but tested negative for EPE, CPE, CRPA and CRAB in screening during study time.

Conditions

Multi-antibiotic Resistance

Study Design

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

Study Groups

patients screened for MDR gram negative bacilli with positive detection

This group has risk factors for acquisition of multidrug resistant gram negative bacilli (e.g hospital admission outside of Scandinavia), and are therefore screened. They have a detection of ESBL producing Enterobacterales (EPE), Carbapenemase producing Enterobacterales (CPE), Carbapenem resistant A.baumannii (CRAB) and/or carbapenem resistant P.aeruginosa (CRPA).

(exposure of) MDR carriage

Intervention Type: OTHER

The difference in exposure between the two groups is the carriage or non-carriage of multidrug resistant gram negative bacilli.

patients screened for MDR gram negative bacilli with negative detection

This group has also similar risk factors for acquisition of multidrug resistant gram negative bacilli (e.g hospital admission outside of Scandinavia), and are therefore screened, but they do not have a detection of EPE, CPE, CRAB and/or CRPA.

No interventions assigned to this group

Interventions

(exposure of) MDR carriage

The difference in exposure between the two groups is the carriage or non-carriage of multidrug resistant gram negative bacilli.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients with a registered screening for MDR.
• screening performed from October 1st 2013 till December 31st 2022.

Exclusion Criteria

• carriers of MDR in question before October 1st 2013.
• patients transferred from other regions.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oskar Ljungquist, M.D PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skane

Central Contacts

Vigith Andrews, M.D

Role: CONTACT

vigith.andrews@med.lu.se

004646176470

Other Identifiers

2023-06402-01

Identifier Type: -

Identifier Source: org_study_id