Bloodstream Infections in Patients With Rheumatoid Arthritis

April 5, 2019 updated by: Sabine Dieperink

Incidence and Risk Factors of Staphylococcus Aureus Bacteremia in Patients With Rheumatoid Arthritis Compared With the General Population

Study of incidence and risk factors of staphylococcus aureus bacteremia in patients with rheumatoid arthritis compared with the general population in a nationwide cohort of all adult members of the population from 1996 until 2017 using national registries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6000000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All individuals alive and living in Denmark on December 31, 1996 as identified by the Civil Registration System are included. Individuals are dynamically included during the study period if they immigrate or turn 18. Individuals are followed up until first-time SAB, death, emigration or December 31, 2017, whichever comes first.

Description

Inclusion Criteria:

  • All members of the adult Danish population

Exclusion Criteria:

  • Staphylococcus aureus bacteremia prior to inclusion.
  • Rheumatoid arthritis diagnosed prior to inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA patients
Incident patients with rheumatoid arthritis as identified by the Danish National Patient Registry and the rheumatology registry, DANBIO.
Other: Risk factors in RA cohort
Other Names:
  • Corticosteroids
  • DMARDs (biologic and synthetic)
  • RA disease activity
  • RA disease duration
  • Tobacco use
  • Joint erosions
  • Prosthetic joints
  • Other comorbid conditions and surgical/dialysis procedures
General population
All other adults, as Identified by the Civil Registration System. Patients who develop RA contribute person-years in the general population cohort until RA diagnosis
Other: Risk factors in general population
Other Names:
  • Prosthetic joints
  • Other comorbid conditions and surgical/dialysis procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of staphylococcus aureus bacteremia
Time Frame: 0-21 years
0-21 years
Incidence rate ratios
Time Frame: 0-21 years
Comparing rheumatoid arthritis patients with the general population
0-21 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors of staphylococcus aureus bacteremia
Time Frame: 0-21 years
Identification of risk factors both universal to both the general population and rheumatoid arthritis (RA) cohorts and RA disease specific factors (disease duration, disease activity, smoking, joint erosions, etc.)
0-21 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sabine Dieperink

Collaborators

University of Copenhagen
University of Aarhus
Statens Serum Institut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 1996

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-SAB2018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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