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Tedizolid Prolonged Treatment for Prosthetic Joint Infections (TEDIZOAM)

Primary Purpose

Prosthetic Joint Infection

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Tedizolid Phosphate 200 MG [Sivextro]

About this trial

This is an interventional treatment trial for Prosthetic Joint Infection focused on measuring Tedizolid, Adverse effects, Efficacy, prosthetic joint infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Ambroise Paré
Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tedizolid Phosphate 200 MG [Sivextro]

Arm Description

All included patients will receive prolonged (>= 6 weeks) tedizolid treatment given orally.

Outcomes

Primary Outcome Measures

Bone marrow toxicity

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.

Peripheral neuropathy

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.

Metabolic acidosis

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.

Serotoninergic syndrome

will be collected to determine the number of adverse event likely to be related to tedizolid treatment.

Retrobulbar optic nevritis

will be collected to determine the number of adverse event likely to be related to tedizolid treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT03378427

First Posted

October 24, 2017

Last Updated

September 6, 2021

Sponsor

Tourcoing Hospital

Collaborators

Eric SENNEVILLE M.D. Ph.D.

1. Study Identification

Unique Protocol Identification Number

NCT03378427

Brief Title

Tedizolid Prolonged Treatment for Prosthetic Joint Infections

Acronym

TEDIZOAM

Official Title

Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

August 28, 2018 (Actual)

Primary Completion Date

October 22, 2020 (Actual)

Study Completion Date

August 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tourcoing Hospital

Collaborators

Eric SENNEVILLE M.D. Ph.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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 the high level of antibiotic resistance of some pathogens. The prolonged intravenous administration of antibiotics exposes the patients to the occurrence of adverse events and it is generally recommended to favor oral treatment provided high oral bioavailable agents can be used with regard to the patient's characteristics and the antibiotic susceptibility profile of the pathogens. Gram positive cocci especially coagulase negative staphylococci (CoNS) are predominant bacteria responsible for orthopedic device infections. The use of the oxazolidinone agent Linezolid in these settings has been validated by some studies in particular in combination with Rifampin but both hematologic, neurologic and metabolic potential toxicity limits treatment durations of more than two to three weeks. The risk of drug-drug interaction with any product having a mono-amine-oxydase inhibitor (MAOI) activity is another limiting problem with Linezolid use. In addition, the wide use of Linezolid has resulted in the emergence of CoNS carrying cfr genes responsible for high levels of Linezolid resistance. This is unfortunate as in many cases there is almost no other alternative for the oral treatment of orthopedic device infections due to these strains. Tedizolid intrinsic properties may improve the oxazolidinone treatment long term safety. Plus tedizolid should be active on CoNS strains resistant to linezolid. Objectives: 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. Hypothesis: As no data are currently available on long term safety of Tedizolid treatment, the investigators will compare the results of the present study regarding tolerance and efficacy with those of a historical cohort of comparable patients from our cohorts treated with Linezolid monotherapy or combination therapy for equivalent indications (data published in Journal of Antimicrobial Chemotherapy Legout L et al..2010). Study Design: Prospective multicenter cohort study. The objectives of the study are : (i) to assess the tolerance of TEDIZOLID determined by the proportion of patients who experienced any adverse event attributable to TEDIZOLID during treatment and during 6 weeks after the antibiotic treatment, and (ii) to assess the efficacy of TEDIZOLID as single agent treatment or combined therapy for orthopedic infections due to TEDIZOLID susceptible bacteria determined by the proportion of patient with remission of the infection (i.e. absence of any local and systemic sign of infection in relation with the initial infection, any surgery for an infectious reason at the initial site or death related to the initial infection) determined one year after the end of the antibiotic treatment. Microbiologic data from failure cases will be recorded in order to assess the presence of Tedizolid-resistant strains, relapsing infections, or superinfection. Treatment: Tedizolid 200 mg once a day, administered orally for the entire treatment will be prescribed in patients after the definite culture results of peroperative samples will be available. Daily doses of the antibiotics associated with tedizolid will be at the discretion of the clinician and will have to follow the institutional therapeutical protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prosthetic Joint Infection

Keywords

Tedizolid, Adverse effects, Efficacy, prosthetic joint infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tedizolid Phosphate 200 MG [Sivextro]

Arm Type

Experimental

Arm Description

All included patients will receive prolonged (>= 6 weeks) tedizolid treatment given orally.

Intervention Type

Drug

Intervention Name(s)

Tedizolid Phosphate 200 MG [Sivextro]

Other Intervention Name(s)

rifampin, ofloxacin, levofloxacin, fusidic acid, clindamycin, teicoplanin, ciprofloxacin, trimethoprim-sulfamethoxazole, doxycycline, minocycline

Intervention Description

Antibiotic treatment (monotherapy or combination) targeting bacteria cultured from per operative samples.

Primary Outcome Measure Information:

Title

Bone marrow toxicity

Description

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.

Time Frame