Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient

NCT06370299 | Not Yet Recruiting

• 1 other identifier: 2023-06402-01
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multi-antibiotic Resistance

Keywords

Multidrug Resistance; Acinetobacter baumannii; Pseudomonas aeruginosa; carbapenem-resistant; gram-negative resistance; ESBL; carbapenemase-producing Enterobacterales; colonization; screening

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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

  within one year of screening

Secondary Outcomes (4)

• prevalence of positive screening results

  through study completion

• prevalence of MDR in clinical samples

  through study completion

• time to first occurrence of phenotypically same MDR as in screening

  through study completion

• prevalence of MDR in clinical samples in patients with negative screening results

  within 30 days of screening

Study Arms (2)

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).

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.

Interventions

(exposure of) MDR carriage OTHER

The difference in exposure between the two groups is the carriage or non-carriage of multidrug resistant gram negative bacilli.

patients screened for MDR gram negative bacilli with positive detection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• patients with a registered screening for MDR.
• screening performed from October 1st 2013 till December 31st 2022.

You may not qualify if:

• carriers of MDR in question before October 1st 2013.
• patients transferred from other regions.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Oskar Ljungquist, M.D PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vigith Andrews, M.D

CONTACT

004646176470; vigith.andrews@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-02