NCT03378427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2021

Completed
Last Updated

September 8, 2021

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

October 24, 2017

Last Update Submit

September 6, 2021

Conditions

Prosthetic Joint Infection

Keywords

TedizolidAdverse effectsEfficacyprosthetic joint infection

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    From date of inclusion until 12 months after the end of treatment

Study Arms (1)

Tedizolid Phosphate 200 MG [Sivextro]

EXPERIMENTAL

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

Drug: Tedizolid Phosphate 200 MG [Sivextro]

Interventions

Tedizolid Phosphate 200 MG [Sivextro]DRUG

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
Tedizolid Phosphate 200 MG [Sivextro]

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Ambroise Paré

Boulogne-Billancourt, 92380, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (17)

  • Titecat M, Senneville E, Wallet F, Dezeque H, Migaud H, Courcol RJ, Loiez C. Microbiologic profile of Staphylococci isolated from osteoarticular infections: evolution over ten years. Surg Infect (Larchmt). 2015 Feb;16(1):77-83. doi: 10.1089/sur.2013.258. Epub 2015 Feb 4.

    PMID: 25650692RESULT

  • Titecat M, Senneville E, Wallet F, Dezeque H, Migaud H, Courcol RJ, Loiez C. Bacterial epidemiology of osteoarticular infections in a referent center: 10-year study. Orthop Traumatol Surg Res. 2013 Oct;99(6):653-8. doi: 10.1016/j.otsr.2013.02.011. Epub 2013 Aug 27.

    PMID: 23988422RESULT

  • Pulcini C, Couadau T, Bernard E, Lorthat-Jacob A, Bauer T, Cua E, Mondain V, Chichmanian RM, Dellamonica P, Roger PM. Adverse effects of parenteral antimicrobial therapy for chronic bone infections. Eur J Clin Microbiol Infect Dis. 2008 Dec;27(12):1227-32. doi: 10.1007/s10096-008-0570-y. Epub 2008 Sep 26.

    PMID: 18818959RESULT

  • Spellberg B, Lipsky BA. Systemic antibiotic therapy for chronic osteomyelitis in adults. Clin Infect Dis. 2012 Feb 1;54(3):393-407. doi: 10.1093/cid/cir842. Epub 2011 Dec 12.

    PMID: 22157324RESULT

  • Morata L, Tornero E, Martinez-Pastor JC, Garcia-Ramiro S, Mensa J, Soriano A. Clinical experience with linezolid for the treatment of orthopaedic implant infections. J Antimicrob Chemother. 2014 Sep;69 Suppl 1:i47-52. doi: 10.1093/jac/dku252.

    PMID: 25135090RESULT

  • Morata L, Senneville E, Bernard L, Nguyen S, Buzele R, Druon J, Tornero E, Mensa J, Soriano A. A Retrospective Review of the Clinical Experience of Linezolid with or Without Rifampicin in Prosthetic Joint Infections Treated with Debridement and Implant Retention. Infect Dis Ther. 2014 Dec;3(2):235-43. doi: 10.1007/s40121-014-0032-z. Epub 2014 Aug 20.

    PMID: 25139552RESULT

  • Senneville E, Legout L, Valette M, Yazdanpanah Y, Beltrand E, Caillaux M, Migaud H, Mouton Y. Effectiveness and tolerability of prolonged linezolid treatment for chronic osteomyelitis: a retrospective study. Clin Ther. 2006 Aug;28(8):1155-1163. doi: 10.1016/j.clinthera.2006.08.001.

    PMID: 16982292RESULT

  • Senneville E, Legout L, Valette M, Yazdanpanah Y, Giraud F, Beltrand E, Obert G, Dubreuil L, Migaud H, Mouton Y. Risk factors for anaemia in patients on prolonged linezolid therapy for chronic osteomyelitis: a case-control study. J Antimicrob Chemother. 2004 Oct;54(4):798-802. doi: 10.1093/jac/dkh409. Epub 2004 Aug 25.

    PMID: 15329363RESULT

  • Legout L, Senneville E, Gomel JJ, Yazdanpanah Y, Mouton Y. Linezolid-induced neuropathy. Clin Infect Dis. 2004 Mar 1;38(5):767-8. doi: 10.1086/381762. No abstract available.

    PMID: 14986270RESULT

  • Legout L, Valette M, Dezeque H, Nguyen S, Lemaire X, Loiez C, Caillaux M, Beltrand E, Dubreuil L, Yazdanpanah Y, Migaud H, Senneville E. Tolerability of prolonged linezolid therapy in bone and joint infection: protective effect of rifampicin on the occurrence of anaemia? J Antimicrob Chemother. 2010 Oct;65(10):2224-30. doi: 10.1093/jac/dkq281. Epub 2010 Jul 29.

    PMID: 20675299RESULT

  • Betriu C, Morales G, Rodriguez-Avial I, Culebras E, Gomez M, Lopez-Fabal F, Picazo JJ. Comparative activities of TR-700 (torezolid) against staphylococcal blood isolates collected in Spain. Antimicrob Agents Chemother. 2010 May;54(5):2212-5. doi: 10.1128/AAC.01653-09. Epub 2010 Feb 22.

    PMID: 20176900RESULT

  • Douros A, Grabowski K, Stahlmann R. Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones. Expert Opin Drug Metab Toxicol. 2015;11(12):1849-59. doi: 10.1517/17425255.2015.1098617. Epub 2015 Oct 12.

    PMID: 26457865RESULT

  • Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

    PMID: 23926058RESULT

  • Flanagan S, McKee EE, Das D, Tulkens PM, Hosako H, Fiedler-Kelly J, Passarell J, Radovsky A, Prokocimer P. Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function. Antimicrob Agents Chemother. 2015 Jan;59(1):178-85. doi: 10.1128/AAC.03684-14. Epub 2014 Oct 20.

    PMID: 25331703RESULT

  • Lodise TP, Bidell MR, Flanagan SD, Zasowski EJ, Minassian SL, Prokocimer P. Characterization of the haematological profile of 21 days of tedizolid in healthy subjects. J Antimicrob Chemother. 2016 Sep;71(9):2553-8. doi: 10.1093/jac/dkw206. Epub 2016 Jun 17.

    PMID: 27317442RESULT

  • Schmidt-Malan SM, Greenwood Quaintance KE, Karau MJ, Patel R. In vitro activity of tedizolid against staphylococci isolated from prosthetic joint infections. Diagn Microbiol Infect Dis. 2016 May;85(1):77-9. doi: 10.1016/j.diagmicrobio.2016.01.008. Epub 2016 Jan 12.

    PMID: 26906190RESULT

  • Morata L, Mensa J, Soriano A. New antibiotics against gram-positives: present and future indications. Curr Opin Pharmacol. 2015 Oct;24:45-51. doi: 10.1016/j.coph.2015.07.004. Epub 2015 Jul 30.

    PMID: 26232669RESULT

MeSH Terms

Interventions

tedizolid phosphateRifampinOfloxacinLevofloxacinFusidic AcidClindamycinTeicoplaninCiprofloxacinTrimethoprim, Sulfamethoxazole Drug CombinationDoxycyclineMinocycline

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingCholestadienolsCholestadienesCholestenesCholestanesSteroidsFused-Ring CompoundsSterolsMembrane LipidsLipidsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingGlycosidesCarbohydratesLipoglycopeptidesGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and ProteinsSulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesDrug CombinationsPharmaceutical PreparationsTetracyclinesNaphthacenesPolycyclic Aromatic Hydrocarbons

Study Officials

  • Eric SENNEVILLE, M.D. Ph. D.

    G. Dron Hospital, Tourcoing, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

December 19, 2017

Study Start

August 28, 2018

Primary Completion

October 22, 2020

Study Completion

August 22, 2021

Last Updated

September 8, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)