Screening of Multidrug Resistant Bacteria, and the Implication of a Positive Screening Result Compared to a Negative on Subsequent Infection and Mortality.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Region Skane
- Enrollment
- 10,000
- Primary Endpoint
- The ratio of the probability of death in patients who are screening positive to the probability of death in patients who are screening negative.
Study Overview
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
- admission rate within a year of screening;
- occurrence rate of other MDR in clinical samples at the time of screening;
- 30-day mortality and one-year mortality.
Secondary objective:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •patients transferred from other regions.
Outcomes
Primary Outcomes
The ratio of the probability of death in patients who are screening positive to the probability of death in patients who are screening negative.
Time Frame: 30 days and one year of screening
relative risk (RR)
The ratio of the probability of antibiotic use in patients who are screening positive to the probability of antibiotic use in patients who are screening negative.
Time Frame: within one year of screening
relative risk
The ratio of the probability of all-cause admission in patients who are screening positive to the probability of all-cause admission in patients who are screening negative.
Time Frame: within one year of screening
relative risk (RR)
Secondary Outcomes
- time to first occurrence of phenotypically same MDR as in screening(through study completion)
- prevalence of MDR in clinical samples(through study completion)
- prevalence of MDR in clinical samples in patients with negative screening results(within 30 days of screening)
- prevalence of positive screening results(through study completion)