Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-07
Brief Title:
Screening of Multidrug Resistant Bacteria and the Clinical Implication for the Patient
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Screening of Multidrug Resistant Bacteria and the Implication of a Positive Screening Result Compared to a Negative on Subsequent Infection and Mortality
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Paeruginosa 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
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 Paeruginosa 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 eg 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 rectumfaeces 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
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 rectumfaeces 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None