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CHROME研究:单剂量和多剂量奥利万星治疗革兰氏阳性感染的真实世界经验

The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections.

作者信息

Redell Mark, Sierra-Hoffman Miguel, Assi Maha, Bochan Markian, Chansolme David, Gandhi Anurag, Sheridan Kathleen, Soosaipillai Ivan, Walsh Thomas, Massey Jill

机构信息

Melinta Therapeutics, Morristown, New Jersey, USA.

Director of Research, Texas A&M affiliated Detar Family Medicine Program & College of Medicine, Victoria, Texas, USA.

出版信息

Open Forum Infect Dis. 2019 Nov 4;6(11):ofz479. doi: 10.1093/ofid/ofz479. eCollection 2019 Nov.

Abstract

BACKGROUND

Oritavancin (ORI) is a long-acting lipoglycopeptide indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible Gram-positive (GP) pathogens.

METHODS

Data collected from a retrospective observational program (2014-2017), Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME), describe the utilization, outcomes, and adverse events (AEs) associated with ORI in 440 patients treated at 26 US sites for ABSSSI and other GP infections.

RESULTS

Clinical success in evaluable patients receiving at least 1 dose of oritavancin was 88.1% (386/438). In a subgroup of patients who received ORI for skin and soft tissue infections (n = 401) and bacteremia (n = 7), clinical success was achieved in 89.0% and 100%, respectively. A cohort of 32 patients received 2-10 ORI doses separated by no more than 14 days for complicated GP infections. Clinical success was observed in 30 of 32 patients (93.8%), including 10 of 11 (90.9%) patients with bone and joint infections and 7 of 8 (87.5%) patients with osteomyelitis. In the safety evaluable population, the overall rate of AEs was 6.6%.

CONCLUSIONS

We describe results from a real-world program that includes the largest multicenter, retrospective, observational study in patients who received at least 1 dose of ORI for the treatment of GP infections. This study confirms that ORI is an effective, well-tolerated antibiotic used in single and multiple doses for the treatment of ABSSSIs and complicated GP infections.

摘要

背景

奥利万星(ORI)是一种长效脂糖肽类药物,用于治疗由易感革兰氏阳性(GP)病原体引起或疑似引起的成人急性细菌性皮肤和皮肤结构感染(ABSSSI)。

方法

从一项回顾性观察项目(2014 - 2017年)、临床与历史登记及奥利万星医学评估(CHROME)收集的数据,描述了在美国26个地点接受治疗的440例ABSSSI和其他GP感染患者使用ORI的情况、治疗结果及不良事件(AE)。

结果

接受至少1剂奥利万星治疗的可评估患者的临床成功率为88.1%(386/438)。在接受ORI治疗皮肤和软组织感染(n = 401)及菌血症(n = 7)的亚组患者中,临床成功率分别为89.0%和100%。一组32例患者因复杂GP感染接受了间隔不超过14天的2 - 10剂ORI治疗。32例患者中有30例(93.8%)观察到临床成功,包括11例骨和关节感染患者中的10例(90.9%)以及8例骨髓炎患者中的7例(87.5%)。在安全性可评估人群中,AE的总体发生率为6.6%。

结论

我们描述了一项真实世界项目的结果,该项目包括了对接受至少1剂ORI治疗GP感染患者的最大规模多中心回顾性观察研究。本研究证实,ORI是一种有效且耐受性良好的抗生素,可单剂量或多剂量用于治疗ABSSSI和复杂GP感染。

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