Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06370299 |
| Other study ID # |
2023-06402-01 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Region Skane |
| Contact |
Vigith Andrews, M.D |
| Phone |
004646176470 |
| Email |
vigith.andrews[@]med.lu.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
