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临床试验/NCT03159403
NCT03159403已完成不适用

Retrospective, Observational Evaluation of the Utilization, Outcomes, and Adverse Events Associated With Orbactiv® for the Treatment of Infections Presumed or Confirmed to be Caused by Gram Positive Bacteria in a Real World Setting

Melinta Therapeutics, Inc.21 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2017年4月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
325
试验地点
21
主要终点
Types Of Primary Infections Being Treated With Oritavancin

研究概览

简要总结

This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The participant was treated with at least one dose of oritavancin for a suspected or confirmed gram positive infection, as monotherapy or part of a broader regimen.
  • At least 60 days has elapsed since the participant received the last dose of oritavancin therapy (prior to data entry into the electronic Case Report Form).

排除标准

  • The participant received oritavancin as a part of a controlled clinical trial.
  • The participant received oritavancin as a part of a Medicines Company-sponsored single or multi-centered pharmacoeconomic outcomes study.

研究组 & 干预措施

Oritavancin

Participants who received at least one dose (at least one for 3 hours per dose) of oritavancin intravenous (IV) as monotherapy or part of a broader regimen. The maximum number of doses to be received by a participant is not known at this time.

干预措施: Oritavancin (Drug)

结局指标

主要结局

Types Of Primary Infections Being Treated With Oritavancin

时间窗: Day 1

The Types Of Primary Infections refers to whether the primary infection was skin or skin structure or other systemic infection (for example, bacteremia, prosthetic joint infection, osteomyelitis).

Classification Of Primary Infections Being Treated With Oritavancin

时间窗: Day 1

The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other.

Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site

时间窗: Up to 30 days after oritavancin IV infusion

All microbiology results during the infection event will be reported. Microbiology results will be noted only for the infection site for which oritavancin (in addition to other agents) is administered or other site related to the primary infection in case of multiple infections. An adverse event was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.

Duration Of Treatment With Oritavancin

时间窗: Day 1 through end of oritavancin IV infusion

The number of days of treatment with oritavancin will be presented.

Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure

时间窗: Up to 30 days after oritavancin IV infusion

Clinical assessments will be based on participant records between end of infusion to 30 days following the last dose of Oritavancin. Clinical categories for assessment include: * Cure - Clinical signs and symptoms are resolved, and no additional antibiotic therapy is necessary for the treatment of the infection * Improved - Partial resolution of clinical signs and symptoms, and no additional antibiotic therapy is necessary for the treatment of the infection * Failure - Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection * Non-evaluable - Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure

Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence

时间窗: Up to 30 days after oritavancin IV infusion

Microbiological assessments will be based on participant records between end of infusion to 30 days following the last dose of oritavancin. Microbiological categories will include only gram positive pathogens believed to be related to the infection process and are defined as: * Microbiologic eradication (the baseline gram positive pathogen has been eradicated) * Microbiologic persistence (the baseline gram positive pathogen persists) * Culture drawn post-oritavancin therapy, but no information regarding microbiologic culture results * No culture collected following the last dose of oritavancin * No information available

Use Of Concomitant Antibiotics With Oritavancin

时间窗: Day 1 through end of oritavancin IV infusion

Concomitant antibiotics include those used between the first and last dose of oritavancin. The number of participants and the type of antibiotic taken will be presented.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (21)

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