A Randomized, Open-Label, Active Controlled Study to Evaluate the Safety and Tolerability of a Phage Cocktail-SPK Therapy in Second Degree Burn Wounds in Adult Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 主要终点
- Incidence of Treatment-Emergent Adverse Events coded by MedDra
研究概览
简要总结
The central aim of this trial is to investigate the safety and tolerability of Phage Cocktail-SPK as an adjunct to standard therapy for the prevention and treatment of burns susceptible to infection/or infected by S. aureus, P. aeruginosa, or K. pneumoniae species. It is hypothesized that no adverse events, clinical abnormalities, or changes in laboratory tests results related to the application of Phage Cocktail SPK Spray will be observed.
详细描述
This is a Phase I, randomized, open-label, active controlled study to evaluate the safety and tolerability of a Phage Cocktail-SPK therapy for second degree burn wounds in adult patients. The wound will be clinically selected on the basis that it is a second degree burn less than 10 percent of total body surface area, and that, according to medical assessment, should heal without surgical intervention. The study is intended to include one site outside of the United States of America, namely the Royal Brisbane and Women's Hospital, in Brisbane, Queensland, Australia.
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
- 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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study
- •Male or female, aged 18 years or older presenting at the emergency department, out-patient burn department or in-hospital patients with a thermal second degree burn wounds (American Burn Association severity classification).
- •Patients with a burn wound covering less than 10% of their total body surface area (TBSA) and present within 7 days of their injury, with or without signs of local infection, expected to heal without the need for surgery.
- •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
- •Current use of dressings containing silver or nanocrystalline silver
- •Pregnancy or lactation
- •Clinical evidence of invasive infection based on American Burn Association consensus conference(Greenhalgh et al., 2007).
- •Burn wounds present in anatomic locations such as burns on the face, hands, feet, genitals, perineum, as well as sites at high risk for developing compartment syndrome (deep circumferential extremity burns).
- •Known allergic reactions to components of Xeroform or Kenacomb.
- •Patients diagnosed with Type I or Type II diabetes.
- •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 PGX-0100.
研究组 & 干预措施
Standard of Care
Standard of care consists of Xeroform primary dressing, a Melolin interface and a crepe. Kenacomb will be used for participants with diagnosed or suspected local infections.
干预措施: Xeroform (Drug)
Cocktail-SPK and standard of care
The experimental drug consists of Cocktail-SPK used as an adjunct to the standard of care. Standard of care consists of Xeroform primary dressing, a Melolin interface and a crepe. Kenacomb will be used for participants with diagnosed or suspected local infections.
干预措施: Bacteriophage cocktail spray (Biological)
Cocktail-SPK and standard of care
The experimental drug consists of Cocktail-SPK used as an adjunct to the standard of care. Standard of care consists of Xeroform primary dressing, a Melolin interface and a crepe. Kenacomb will be used for participants with diagnosed or suspected local infections.
干预措施: Xeroform (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events coded by MedDra
时间窗: At least 14 days
Safety of Phage cocktail-SPK will be measured by the number and percent of treatment related adverse events
Incidence of treatment discontinuation due to adverse events
时间窗: 14 days
Tolerability of Phage Cocktail-SPK will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events
次要结局
- Assess if Phage Cocktail-SPK can prevent or reduce S. aureus, P. aeruginosa, or K. pneumoniae wound colonization.(14 days)