ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)

NCT03826108 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2019-08-09

No results posted yet for this study

Summary

The number of arthroplasties is expected to grow in the next few years. Staphylococcus aureus (SA) is a primary cause of prosthetic joint infection (PJI) with serious consequences. This microorganism is frequently associated with treatment failure, hospitalizations and need of prosthesis removal, leading to an important morbidity and an increase in healthcare costs.

ARTHR-IS is a retrospective multi-center study which aims to estimate the burden of SA-PJI after a hip or knee arthroplasty and their risk factors. Other objectives are to quantify the costs, the number of hospitalizations and the surgical procedures needed to treat and control the infection and finally the factors influencing therapeutic failure.

Through a case-control design, ARTHR-IS will group 20 hospitals across 5 European countries in order to include 150 cases and 450 controls.

The results of this study will provide critical information to develop strategies to prevent and treat SA-PJI and reduce treatment failures. Also, the results from ARTH-IS study will help in the design of future clinical trials in prosthesis infections by providing reliable estimates on the incidence of SA-PJI and the subsequent burden on health care services.

Conditions

  • Staphylococcus Aureus
  • Prosthetic Joint Infection
  • Arthroplasty Complications

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • Hospital Universitario Virgen Macarena

    collaborator OTHER
  • UMC Utrecht

    collaborator OTHER
  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2020-05-01
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826108 on ClinicalTrials.gov