An interventional study of Tedizolid Phosphate 200 MG [Sivextro] in Prosthetic Joint Infection, sponsored by Tourcoing Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Tourcoing Hospital · Not applicable, Interventional, and Treatment
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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.
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.
Tourcoing Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: rifampin, ofloxacin, levofloxacin, fusidic acid, clindamycin, teicoplanin, ciprofloxacin, trimethoprim-sulfamethoxazole, doxycycline, minocycline
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.
Time frame: From date of inclusion until 12 months after the end of 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.
Time frame: From date of inclusion until 12 months after the end of 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.
Time frame: From date of inclusion until 12 months after the end of treatment
Serotoninergic syndrome
will be collected to determine the number of adverse event likely to be related to tedizolid treatment.
Time frame: From date of inclusion until 12 months after the end of treatment
Retrobulbar optic nevritis
will be collected to determine the number of adverse event likely to be related to tedizolid treatment.
Time frame: From date of inclusion until 12 months after the end of treatment
Plan to share: No
Ran from Aug 2018 to primary completion in Oct 2020, 25 months.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tedizolid phosphate
Tourcoing Hospital