A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Frequency of relapse of infection
研究概览
简要总结
This will be a pilot single-arm study consisting of 15 participants evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users.
The purpose of this pilot proposal is to collect information for a subsequent large, randomized intervention. Primary endpoints will be 1) Safety and tolerability, and 2) Duration of hospitalization and rate of recurrence.
详细描述
This will be an early phase, single center, open label pilot study of 15 participants designed to evaluate the effects of oritavancin in patients with Opioid Use Disorder and/or Intravenous Drug Use and systemic S. aureus infections. In this study systemic infections refers to bacteremia or Infectious Endocarditis. Participants who meet inclusion and exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for IE. Participants will be evaluated weekly until completion of treatment and then at week 4 and week 6 after the infusion of oritavancin. Participants will have blood drawn at each visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by culture for the presence of relapse of the infection. At the last visit, participants will have an echocardiogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Systemic infection with S. aureus
- •Afebrile for >48 hours
- •Negative blood cultures for at least 48 hours
- •Absolute neutrophil count (ANC) equal or greater 750/mm3
- •Hemoglobin > 9.0 g/dL
- •Platelet count equal or > 50,000/mm3
- •Creatinine < 2.0 x ULN
- •AST ; ALT, and alkaline phosphatase < 2.0 x ULN
- •Willing to use a medically accepted method of contraception
排除标准
- •Require valve replacement surgery
- •Have prosthetic material in body (This includes prosthetic heart valves and/or prosthetic joints)
- •Septic emboli to central nervous system or lungs
- •Breast feeding during entire participation
- •Polymicrobial infection
- •Require anticoagulation
- •Allergy to vancomycin or oritavancin
研究组 & 干预措施
Oritavancin
Single IV infusion of 1200mg of oritavancin
干预措施: Oritavancin Injection (Drug)
结局指标
主要结局
Frequency of relapse of infection
时间窗: 6 weeks
Efficacy
Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin
时间窗: 6 weeks
Safety
次要结局
- Duration of hospitalization(6 weeks)
- Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)(6 weeks)
- Relapse of systemic S. aureus infections(6 weeks)
- Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)(6 weeks)