A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Potential Efficacy of BACTELIDE vs. Placebo in Addition to Standard-of-care Therapy for S. Aureus, P. Aeruginosa, and K. Pneumoniae Colonized Pressure Injuries
试验速览
- 阶段
- 1 期
- 入组人数
- 69
- 主要终点
- Incidence of Treatment-Emergent Adverse Events coded by MedDra
研究概览
简要总结
This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.
This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.
详细描述
The central aim of this study is to investigate the safety, tolerability, and indicative efficacy of a single dose of a phage therapy combination product, BACTELIDE, as an adjunct to standard therapy in participants presenting with a Stage II, III or IV pressure injuries with positive wound cultures for S. aureus, P. aeruginosa, or K. pneumoniae at screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Stated willingness to comply with lifestyle considerations
- •Male or female, 18 years or older presenting in long-term care facilities, out-patient department or in-hospital patients with a stage II, III or IV pressure injury with or without local signs of infection with a size not exceeding 28 cm2
- •Within 72 hours before randomization, pressure injury specimen positive for S. aureus, P. aeruginosa, or K. pneumoniae determined by qPCR or rapid diagnostic test or conventional method or positive growth on specific agar.
- •For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of administration of the study intervention
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
排除标准
- •Diagnosis of Kennedy terminal ulcer, Trombley-Brennan terminal tissue injuries or skin changes at life's end (SCALE).
- •Pregnancy or lactation.
- •Known allergic reactions to components of SilvaSorb hydrogel.
- •Known allergic reactions to components of the phage treatment; including known allergic reactions to bacteriophages, polyester amide urea polymers and/or TMN buffer.
- •Unstable coronary artery disease.
- •Patients diagnosed with Type I or Type II diabetes, uncontrolled (HgbA1c >8% or 2+ glycosuria).
- •Treatment with another investigational drug or other intervention within 30 days.
- •Intercurrent condition requiring a high dose of chronic corticosteroid therapy, immunosuppressive medication, oncologic chemotherapy.
- •Patients who have additional uncontrolled serious medical or psychiatric illness determined by the investigators where the patient is unfit to receive the product.
- •Chronic stool incontinence without a rectal tube if an individual has a sacral ulcer.
- •Placement of a wound vacuum.
- •Surgical wound closure planned within the study period.
- •Organ failure, acute respiratory failure and chronic renal failure.
- •Diagnosed osteomyelitis.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events coded by MedDra
时间窗: At least 56 days
Safety of BACTELIDE will be measured by the number and percent of treatment related adverse events.
Incidence of treatment discontinuation due to adverse events
时间窗: 56 days
Tolerability of BACTELIDE will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events
次要结局
- Assess the effect of BACTELIDE on the rate of wound progression.(56 days)
- Assess the effect of BACTELIDE on the incidence of bacterial colonization by S. aureus, P. aeruginosa, or K. pneumoniae species in pressure injury wounds.(28 days)
- Assess if BACTELIDE can improve the clinical outcome by preventing or treating wound infection.(28 days)