Phase I/II Clinical Trial Randomized, Multicentric, Open Label, Standard of Care (Silver Sulfadiazine) Controlled Aiming at Assessing Tolerance and Efficacy of Local Bacteriophage Treatment of Wound Infections Due to E. Coli or P. Aeruginosa in Burned Patients Using Pherecydes Pharma Anti-Escherichia Coli and Anti-Pseudomonas Aeruginosa Bacteriophages GMP Produced Cocktails . This Project is a European Research & Development (R&D) Project Funded by the European Commission Under the 7th Framework Programme for Research and Development Involving 7 Clinical Sites in EU.
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 5
- 主要终点
- Time for bacteria reduction adjusted on antibiotic treatment
研究概览
简要总结
The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.
详细描述
PHAGOBURN is a Phase I/II clinical trial randomized, multicentric, open label, standard of care (Silver Sulfadiazine) controlled aiming at assessing tolerance and efficacy of local bacteriophage treatment of wound infections due to E. coli or P. aeruginosa in burned patients using Pherecydes Pharma anti-Escherichia coli and anti-Pseudomonas aeruginosa bacteriophage cocktails GMP produced. This project is a European Research & Development (R&D) project funded by the European Commission under the 7th Framework Programme for Research and Development. This project is involving 7 clinical sites in EU.
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
- •Man or woman
- •Adult Informed consent obtained from patient or next of kin
- •In-hospital patient treated for burn wounds in a burn unit
- •Burn wound (grafted or not) or graft harvesting area, presenting local signs of infection defined by SFETB criteria:
- •A local or loco-regional inflammatory reaction;
- •And/or an adverse and unexpected local evolution;
- •And/or regarding burn wounds: presence of pus, fast spontaneous debridement and separation, occurrence of blackish spots (necrosis or haemorrhage), unexplained conversion from a superficial lesion to a deep one (> 48th hour);
- •And/or regarding graft donor sites: presence of pus, unexplained delay in epidermisation, bedsore;
- •And/or regarding graft recipient sites: presence of pus, lysis of grafts, necrosis of fat located under the graft.
- •Burn wounds with a microbiologically documented infection, as defined by positive surface swab, due to Escherichia coli or Pseudomonas aeruginosa whatever their resistance profile
- •Treated by povidone-iodine
排除标准
- •Pregnant or breastfeeding woman
- •Intercurrent condition requiring a treatment which may interfere with analysis results: such as high dose of chronic corticotherapy, immunosuppressive medication, oncologic chemotherapy
- •Patient included in an interventional research protocol with therapeutic intervention still ongoing upon inclusion time or having participated into anti-infective drug trials during the previous month.
- •Patient considered as part of a vulnerable population
- •Patient for whom treatment limitation or withdrawal during study period is considered
- •Allergy to Silver Sulfadiazine
研究组 & 干预措施
E. coli, Phages cocktail
Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail
干预措施: E. coli Phages cocktail (Drug)
P. aeruginosa, Phages cocktail
Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail
干预措施: P. Aeruginosa, Phages cocktail (Drug)
结局指标
主要结局
Time for bacteria reduction adjusted on antibiotic treatment
时间窗: 7 days
Time necessary for a persistent bacteria reduction of two modes or persistent bacteria eradication relative to D0 adjusted on antibiotic treatment (active on targeted strain) introduced between D1 to D7. Bacteria count performed on bacteria targeted by the phages cocktail collected from surface swab samples assessed by the microbiologist.
次要结局
- Assessment of tolerance of treatment(21 days)
- Incidence an delay of infection reduction with different bacterial species from the targets(7 days)
- number of sites cured(7 days)