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Trial record 10 of 50 for:    "Prosthetic Joint Infection"

Tedizolid Prolonged Treatment for Prosthetic Joint Infections (TEDIZOAM)

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ClinicalTrials.gov Identifier: NCT03378427
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Eric SENNEVILLE M.D. Ph.D.
Information provided by (Responsible Party):
Tourcoing Hospital

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 patients with orthopedic device infections due to Gram positive cocci.

Condition or disease Intervention/treatment Phase
Prosthetic Joint Infection Drug: Tedizolid Phosphate 200 MG [Sivextro] Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : January 15, 2020


Arm Intervention/treatment
Experimental: Tedizolid Phosphate 200 MG [Sivextro]
All included patients will receive prolonged (>= 6 weeks) tedizolid treatment given orally.
Drug: Tedizolid Phosphate 200 MG [Sivextro]
Antibiotic treatment (monotherapy or combination) targeting bacteria cultured from per operative samples.
Other Names:
  • rifampin
  • ofloxacin
  • levofloxacin
  • fusidic acid
  • clindamycin
  • teicoplanin
  • ciprofloxacin
  • trimethoprim-sulfamethoxazole
  • doxycycline
  • minocycline




Primary Outcome Measures :
  1. Bone marrow toxicity [ Time Frame: From date of inclusion until 12 months after the end of treatment ]
    assessed on the values of hemoglobin, leucocytes, neutrophils and platelets counts, will be collected to determine the number of adverse event likely to be related to tedizolid treatment.

  2. Peripheral neuropathy [ Time Frame: From date of inclusion until 12 months after the end of treatment ]
    Paresthesia, dysesthesia, hypoesthesia, allodynia (confirmed by EMG examination), will be collected to determine the number of adverse event likely to be related to tedizolid treatment.

  3. Metabolic acidosis [ Time Frame: From date of inclusion until 12 months after the end of treatment ]
    dyspnea of unknown origin ; pH < 7.35 ; [ HCO3− ] < 22 mmol/L ; paCO2 < 45 mmHg ; lactates > 2 mmol/L, will be collected to determine the number of adverse event likely to be related to tedizolid treatment.

  4. Serotoninergic syndrome [ Time Frame: From date of inclusion until 12 months after the end of treatment ]
    will be collected to determine the number of adverse event likely to be related to tedizolid treatment.

  5. Retrobulbar optic nevritis [ Time Frame: From date of inclusion until 12 months after the end of treatment ]
    will be collected to determine the number of adverse event likely to be related to tedizolid treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378427


Locations
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France
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92380
Hôpital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
Tourcoing Hospital
Eric SENNEVILLE M.D. Ph.D.
Investigators
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Study Chair: Eric SENNEVILLE, M.D. Ph. D. G. Dron Hospital, Tourcoing, France

Publications of Results:

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Responsible Party: Tourcoing Hospital
ClinicalTrials.gov Identifier: NCT03378427     History of Changes
Other Study ID Numbers: 2017-001238-24
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tourcoing Hospital:
Tedizolid
Adverse effects
Efficacy
prosthetic joint infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Tedizolid
Tedizolid phosphate
Sulfamethoxazole
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors