Dataset Information

Tolerance of Prolonged Oral Tedizolid for Prosthetic Joint Infections: Results of a Multicentre Prospective Study.

ABSTRACT:

Objectives

Data on clinical and biological tolerance of tedizolid (TZD) prolonged therapy are lacking.

Methods

We conducted a prospective multicentre study including patients with prosthetic joint infections (PJIs) who were treated for at least 6 weeks but not more than 12 weeks.

Results

Thirty-three adult patients of mean age 73.3 ± 10.5 years, with PJI including hip (n = 19), knee (n = 13) and shoulder (n = 1) were included. All patients were operated, with retention of the infected implants and one/two stage-replacements in 11 (33.3%) and 17/5 (51.5%/15.2%), respectively. Staphylococci and enterococci were the most prevalent bacteria identified. The mean duration of TZD therapy was 8.0 ± 3.27 weeks (6-12). TZD was associated with another antibiotic in 18 patients (54.5%), including rifampicin in 16 cases (48.5). Six patients (18.2%) had to stop TZD therapy prematurely because of intolerance which was potentially attributable to TZD (n = 2), early failure of PJI treatment (n = 2) or severe anaemia due to bleeding (n = 2). Regarding compliance with TZD therapy, no cases of two or more omissions of medication intake were recorded during the whole TZD treatment duration.

Conclusions

These results suggest good compliance and a favourable safety profile of TZD, providing evidence of the potential benefit of the use of this agent for the antibiotic treatment of PJIs.

SUBMITTER: Senneville E

PROVIDER: S-EPMC7824147 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Tolerance of Prolonged Oral Tedizolid for Prosthetic Joint Infections: Results of a Multicentre Prospective Study.

Senneville Eric E Dinh Aurélien A Ferry Tristan T Beltrand Eric E Blondiaux Nicolas N Robineau Olivier O

Antibiotics (Basel, Switzerland) 20201223 1

<h4>Objectives</h4>Data on clinical and biological tolerance of tedizolid (TZD) prolonged therapy are lacking.<h4>Methods</h4>We conducted a prospective multicentre study including patients with prosthetic joint infections (PJIs) who were treated for at least 6 weeks but not more than 12 weeks.<h4>Results</h4>Thirty-three adult patients of mean age 73.3 ± 10.5 years, with PJI including hip (<i>n</i> = 19), knee (<i>n</i> = 13) and shoulder (<i>n</i> = 1) were included. All patients were operated ...[more]

PMID: 33374817

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Project description:Bone and joint infections (BJIs) are common infections increasingly managed with oral therapy. However, there are limited safe oral options for many Gram-positive pathogens. In animal studies and short-term human use, tedizolid lacks the hematologic and neurologic toxicity of the other available oxazolidinone, linezolid. However, there are limited prospective safety data. We conducted an open-label, non-comparative trial of oral tedizolid for BJI treatment. Primary outcomes were safety and cure rate. Eligible patients had a BJI caused by documented or suspected Gram-positive pathogen, required 4-12 weeks of therapy, and did not have myelosuppression or peripheral/optic neuropathy. Subjects underwent weekly evaluation for cytopenias and neuropathy. We enrolled 44 subjects; five were lost to follow-up. Two subjects did not complete planned treatment because of rash (n = 1) and urgent surgery (n = 1). Of 37 patients with evaluable outcomes, 17 (46%) had hardware-associated infection, 13 (35%) had osteomyelitis, 5 (14%) had prosthetic joint infection, and 2 (5%) had other BJIs. Median (mean, range) treatment duration was 12 (10.1, 4-12) weeks. There were no cases of cytopenias or peripheral or optic neuropathy. Treatment cure occurred in 13 (35%); 19 (51%) required antibiotic continuation after 12 weeks of tedizolid related to retained hardware at the BJI site, and failure occurred in four (11%), two unlikely, one possibly, and one probably due to tedizolid. We found that oral tedizolid was well tolerated for prolonged BJI treatment without significant toxicity. Clinical failure rate was similar to that of other published BJI investigations. (This study has been registered at Clinicaltrials.gov under identifier NCT03009045.) IMPORTANCE Bone and joint infections are common infections with limited effective and safe oral options for Gram-positive infections. The largest prospective clinical trial of tedizolid therapy for bone and joint infections enrolled 44 patients and tested each in person weekly with detailed safety monitoring including tests for leukopenia, anemia, thrombocytopenia, peripheral neuropathy, and optic neuropathy for up to 12 weeks. Findings demonstrated tedizolid was generally well tolerated and there were no incident cases of cytopenias or neuropathy. Cure rates were similar to that in other bone and joint infection studies. In summary, oral tedizolid appears to be a well-tolerated oral option for Gram-positive bone and joint infections.

Project description:ImportanceDentists in the United States are under pressure from orthopedic surgeons and their patients with prosthetic joints to provide antibiotic prophylaxis before invasive dental procedures (IDP) to reduce the risk of late prosthetic joint infection (LPJI). This has been a common practice for decades, despite a lack of evidence for an association between IDP and LPJI, a lack of evidence of antibiotic prophylaxis efficacy, cost of providing antibiotic prophylaxis, and risk of both adverse drug reactions and the potential for promoting antibiotic resistance.ObjectiveTo quantify any temporal association between IDP and subsequent LPJI.Design, setting, and participantsThis cohort study used a case-crossover and time trend design to examine any potential association between IDP and LPJI. The population of England (55 million) was chosen because antibiotic prophylaxis has never been recommended to prevent LPJI in England, and any association between IDP and LPJI would therefore be fully exposed. All patients admitted to hospitals in England for LPJI from December 25, 2011, through March 31, 2017, and for whom dental records were available were included. Analyses were performed between May 2018 and June 2021.ExposuresExposure to IDP.Main outcomes and measuresThe main outcome was the incidence of IDP in the 3 months before LPJI hospital admission (case period) compared with the incidence in the 12 months before that (control period).ResultsA total of 9427 LPJI hospital admissions with dental records (mean [SD] patient age, 67.8 [13.1] years) were identified, including 4897 (52.0%) men and 4529 (48.0%) women. Of these, 2385 (25.3%) had hip prosthetic joints, 3168 (33.6%) had knee prosthetic joints, 259 (2.8%) had other prosthetic joints, and 3615 (38.4%) had unknown prosthetic joint types. There was no significant temporal association between IDP and subsequent LPJI. Indeed, there was a lower incidence of IDP in the 3 months prior to LPJI (incidence rate ratio, 0.89; 95% CI, 0.82-0.96; P = .002).Conclusions and relevanceThese findings suggest that there is no rationale to administer antibiotic prophylaxis before IDP in patients with prosthetic joints.

Dataset Information

Tolerance of Prolonged Oral Tedizolid for Prosthetic Joint Infections: Results of a Multicentre Prospective Study.

Objectives

Methods

Results

Conclusions

Publications

Tolerance of Prolonged Oral Tedizolid for Prosthetic Joint Infections: Results of a Multicentre Prospective Study.

Similar Datasets

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