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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Vigith Andrews, M.D contact

004646176470

vigith.andrews@med.lu.se

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

  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.

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 groups in NCT06370299
Study groupRoleWhat they receive
patients screened for MDR gram negative bacilli with positive detectionThis 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 detectionThis 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.

  1. 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

  2. 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

  3. 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)
  1. prevalence of positive screening results

    number and percent

    Measured: through study completion

  2. prevalence of MDR in clinical samples

    number and percent

    Measured: through study completion

  3. time to first occurrence of phenotypically same MDR as in screening

    days, months, years

    Measured: through study completion

  4. 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.

  1. First posted17 Apr 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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)
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.

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.

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