Sims Charles R, Bressler Adam M, Graham Donald R, Lacy Melinda K, Lombardi David A, Castaneda-Ruiz Bibiana
Baylor CHI St Luke's Health, The Woodlands, TX, USA.
Infectious Disease Specialists of Atlanta, Decatur, GA, USA.
Drugs Real World Outcomes. 2021 Dec;8(4):509-518. doi: 10.1007/s40801-021-00255-6. Epub 2021 May 26.
Additional antibiotic options are needed to treat bone and joint infections caused by penicillin-resistant Gram-positive pathogens.
This subanalysis of the Telavancin Observational Use Registry (TOUR™) aimed to record real-world telavancin usage patterns in patients with bone and joint infections treated with telavancin.
TOUR was a multicenter observational-use registry study conducted at 45 US sites between January 2015 and March 2017. Patient characteristics, infection type, infecting pathogen(s), previous treatment, telavancin dosing and duration, clinical response, and adverse event data were collected by retrospective medical chart reviews. As such, inclusion/exclusion criteria were limited, and any patient receiving at least one dose of telavancin at the discretion of the treating physician was eligible. Patients were assessed as either positive clinical response, failed treatment, or indeterminate outcome.
Of the 1063 patients enrolled in TOUR, 27.4% (291/1063) were patients with bone and joint infections including osteomyelitis (with or without prosthetic material), acute septic arthritis, and prosthetic joint infections. Most of these patients had osteomyelitis without prosthetic material (191/291; 66.0%). Among patients assessed at the end of treatment, 211/268 (78.7%) achieved a positive clinical response, 26/268 (9.7%) failed treatment, and 31/268 (11.6%) had an indeterminate outcome. The most frequent pathogen was methicillin-resistant Staphylococcus aureus (110/291; 37.8%). The median (interquartile range [IQR as Q1, Q3]) telavancin dose was 750.0 mg (IQR, 750, 750 mg) or 8.2 mg/kg (IQR, 6.8, 9.7 mg/kg) administered for a median of 26 days (IQR, 12, 42 days). These assessments were recorded in the registry ≥ 30 days after the last dose of telavancin was administered.
Real-world data from the TOUR study show that clinicians are using once-daily telavancin with positive clinical outcomes for the treatment of bone and joint infections caused by Gram-positive pathogens.
This trial was registered with ClinicalTrials.gov (NCT02288234) on 11 November, 2014.
治疗由耐青霉素革兰氏阳性病原体引起的骨和关节感染需要更多抗生素选择。
替拉万星观察性使用登记研究（TOUR™）的这项子分析旨在记录接受替拉万星治疗的骨和关节感染患者的替拉万星实际使用模式。
TOUR是一项多中心观察性使用登记研究，于2015年1月至2017年3月在美国45个地点进行。通过回顾性病历审查收集患者特征、感染类型、感染病原体、既往治疗、替拉万星剂量和疗程、临床反应及不良事件数据。因此，纳入/排除标准有限，任何经治疗医生酌情给予至少一剂替拉万星的患者均符合条件。患者被评估为临床反应阳性、治疗失败或结果不确定。
在TOUR登记的1063例患者中，27.4%（291/1063）为骨和关节感染患者，包括骨髓炎（有无假体材料）、急性化脓性关节炎和人工关节感染。这些患者中大多数患有无假体材料的骨髓炎（191/291；66.0%）。在治疗结束时评估的患者中，211/268（78.7%）临床反应阳性，26/268（9.7%）治疗失败，31/268（11.6%）结果不确定。最常见的病原体是耐甲氧西林金黄色葡萄球菌（110/291；37.8%）。替拉万星的中位（四分位间距[IQR为Q1，Q3]）剂量为750.0mg（IQR，750，750mg）或8.2mg/kg（IQR，6.8，9.7mg/kg），中位给药26天（IQR，12，42天）。这些评估在最后一剂替拉万星给药≥30天后记录在登记处。
TOUR研究的实际数据表明，临床医生正在每日一次使用替拉万星治疗革兰氏阳性病原体引起的骨和关节感染，临床结果良好。
本试验于2014年11月11日在ClinicalTrials.gov（NCT02288234）注册。
