Status:

COMPLETED

Tedizolid Prolonged Treatment for Prosthetic Joint Infections

Lead Sponsor:

Tourcoing Hospital

Collaborating Sponsors:

Eric SENNEVILLE M.D. Ph.D.

Conditions:

Prosthetic Joint Infection

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Pilot study the aim of which is to obtain reliable data on the tolerance, compliance and efficacy of Tedizolid used as prolonged (≥ 6 weeks) monotherapy or in combination therapy for the treatment of ...

Detailed Description

Background: The antibiotic treatment of patients with orthopedic device infections (e.g. prosthetic joint and osteosynthesis) is limited by the tolerance of prolonged administration of antibiotics and...

Eligibility Criteria

Inclusion

  • Patient at least 18 years;
  • Orthopedic device infection defined according to the French recommendations published in 2009 (Med Mal Infect 2009; 39:745-774) for which TEDIZOLID treatment is proposed according to the investigator's decision;
  • Bacterial documentation of the infection will only be based on the results of reliable samples such as joint aspiration and peroperative samples.
  • Requiring TEDIZOLID administration as a single antibiotic therapy or in combination therapy including another agent with proven activity against the involved pathogen(s);
  • No contraindication to TEDIZOLID;
  • Provide a signed informed consent for the trial.

Exclusion

  • pregnant women or of childbearing age without contraception, breastfeeding,
  • intolerance to TEDIZOLID;
  • allergy to LINEZOLID;
  • bactéria non susceptible to TEDIZOLID;
  • patient with uncertainty regarding the possibility to achieve one-year follow-up after the end of treatment.

Key Trial Info

Start Date :

August 28 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 22 2021

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT03378427

Start Date

August 28 2018

End Date

August 22 2021

Last Update

September 8 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Hôpital Ambroise Paré

Boulogne-Billancourt, France, 92380

2

Hôpital de la Croix Rousse

Lyon, France, 69004