Multi-antibiotic ResistanceNCT06370299
Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient
An observational study of Multi-antibiotic Resistance, run by Region Skane.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multi-antibiotic Resistance
- What is being tested?
- (exposure of) MDR carriage
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population of Scania region in Sweden consisting of 1.4 million inhabitants. At the time of admission to a hospital in Scania, patients with risk factors for acquisition of MDR undergo screening for MDR carriage. Screenings for MDR are carried out according to local guideline "Suspected MDR - routines for hospitalized patients" and analysed and reported from the one Department of Clinical Microbiology in Lund in Scania region.
Who may be able to join
- patients with a registered screening for MDR.
- screening performed from October 1st 2013 till December 31st 2022.
Who cannot join
- carriers of MDR in question before October 1st 2013.
- patients transferred from other regions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Screening of Multidrug Resistant Bacteria, and the Implication of a Positive Screening Result Compared to a Negative on Subsequent Infection and Mortality.
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.
Read the 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:
- To evaluate the prevalence of positive screening results;
- To characterize the MDR species and their phenotypical and genotypical resistance mechanisms;
- To evaluate prevalence of MDR in clinical samples and time to first occurrence of phenotypically same MDR;
- 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
- Being tested
- (exposure of) MDR carriage
- Keywords
- Multidrug Resistance, Acinetobacter baumannii, Pseudomonas aeruginosa, carbapenem-resistant, gram-negative resistance, ESBL, carbapenemase-producing Enterobacterales, colonization, screening
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(exposure of) MDR carriageOther
The difference in exposure between the two groups is the carriage or non-carriage of multidrug resistant gram negative bacilli.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: (exposure of) MDR carriage | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
relative risk (RR)
Measured: within one year of screening
The ratio of the probability of death in patients who are screening positive to the probability of death in patients who are screening negative.
relative risk (RR)
Measured: 30 days and one year of screening
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.
relative risk
Measured: within one year of screening
Secondary outcomes (4)
prevalence of positive screening results
number and percent
Measured: through study completion
prevalence of MDR in clinical samples
number and percent
Measured: through study completion
time to first occurrence of phenotypically same MDR as in screening
days, months, years
Measured: through study completion
prevalence of MDR in clinical samples in patients with negative screening results
number and percent
Measured: within 30 days of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-antibiotic ResistanceStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Oskar Ljungquist, M.D PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370299
- Sponsor's protocol ID
- 2023-06402-01
- Other IDs
- 2023
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets analysed during the current study will not be publicly available due to the Swedish Data Protection Act, but will probably be available from the corresponding author on reasonable request, after approval has been given by the Swedish Data Protection Agency.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Multidrug Resistant Bacteria, and the Implication of a Positive Screening Result Compared to a Negative on Subsequent Infection and Mortality.
- ClinicalTrials.gov ID
- NCT06370299
- Acronym / sponsor ID
- 2023-06402-01
- Conditions
- Multi-antibiotic Resistance
- Keywords
- Multidrug Resistance, Acinetobacter baumannii, Pseudomonas aeruginosa, carbapenem-resistant, gram-negative resistance, ESBL, carbapenemase-producing Enterobacterales, colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the prevalence of positive screening results;
- To characterize the MDR species and their phenotypical and genotypical resistance mechanisms;
- To evaluate prevalence of MDR in clinical samples and time to first occurrence of phenotypically same MDR;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients screened for MDR gram negative bacilli with positive detection | – | Other: (exposure of) MDR carriageThis 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). |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population of Scania region in Sweden consisting of 1.4 million inhabitants. At the time of admission to a hospital in Scania, patients with risk factors for acquisition of MDR undergo screening for MDR carriage. Screenings for MDR are carried out according to local guideline "Suspected MDR - routines for hospitalized patients" and analysed and reported from the one Department of Clinical Microbiology in Lund in Scania region.
Key inclusion criteria (2 listed)
- patients with a registered screening for MDR.
- screening performed from October 1st 2013 till December 31st 2022.
Key exclusion criteria (2 listed)
- carriers of MDR in question before October 1st 2013.
- patients transferred from other regions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (exposure of) MDR carriageThe difference in exposure between the two groups is the carriage or non-carriage of multidrug resistant gram negative bacilli. | Other | patients screened for MDR gram negative bacilli with positive detection |
Primary outcome
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)
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
4 secondary outcomes
prevalence of positive screening results
Time frame: through study completion
prevalence of MDR in clinical samples
Time frame: through study completion
time to first occurrence of phenotypically same MDR as in screening
Time frame: through study completion
prevalence of MDR in clinical samples in patients with negative screening results
Time frame: within 30 days of screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided. The datasets analysed during the current study will not be publicly available due to the Swedish Data Protection Act, but will probably be available from the corresponding author on reasonable request, after approval has been given by the Swedish Data Protection Agency.
Related trials for Multi-antibiotic Resistance
Active, not recruitingPhase 2
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Multi-Drug Resistant Organism Colonization
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Recruiting
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
Sepsis, Neonatal Mortality
RecruitingPhase 1
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
Infectious Diseases, Antimicrobial Drug Resistance
RecruitingPhase 3
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
MDR-TB, Tuberculosis Multi Drug Resistant Active
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oskar Ljungquist, M.D PhD principal investigator
Region Skane
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-antibiotic Resistance, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vigith Andrews, M.D (004646176470, vigith.andrews@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.