A Phase 2 CT to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients With DFI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 10
- 主要终点
- 3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4
研究概览
简要总结
TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).
详细描述
This is a Phase 2b, double-blinded, randomised, placebo-controlled multicenter study to determine the safety and efficacy of TP-102, in patients with diabetic foot infection.
Eighty (80) patients with an infected diabetic foot ulcer and with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii) susceptible to TP-102.
Patients will be randomised to receive TP-102 or placebo, in a 1:1 ratio. Patients will be treated with 1 (one) mL of IP/ Placebo solution applied topically per cm3 of target ulcer. Patients will be treated with a total of 12 treatments in 28 days (+3 days) with at least one day of interval in between the days of treatment (no consecutive days of treatment are allowed) and a maximum of 3 (three) days without treatment.
The titre of each bacteriophage in TP-102 is 1x109 (>1x108 and < 1x1010) plaque forming units per milliliter (PFU/mL).
Assessments for efficacy and safety will include concomitant medications and AEs, local tolerability, clinical laboratory tests, vital signs, physical examination, wound biopsy/swab to determine the presence, speciation and TP-102 sensitivity of bacteria and target ulcer assessment.
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
- •Aged ≥18 years old;
- •Established diagnosis of Diabetes Mellitus (type I or II);
- •Glycosylated hemoglobin (HbA1c) value < 12.0%;
- •Designated foot infection meets the following criteria:
- •Present for at least 3 weeks;
- •Below-ankle, full-thickness, cutaneous ulcer;
- •Wound area (after debridement, if applicable) 1 to 20.0 cm2;
- •PEDIS infection grade 2 or 3;
- •PEDIS perfusion grade 1 or 2;
- •PEDIS depth grade 1 or 2 (grade 3 at the discretion of the investigator e.g. if they have received appropriate surgical treatment to remove infected bones).
- •Diabetic foot infection with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to the TP-102 bacteriophage cocktail, as assessed from wound cultures;
- •Patients of suitable physical and mental health as determined by the Investigator on the basis of medical history and general physical examination;
- •Patients of childbearing potential must have a negative serum pregnancy test at screening;
- •ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required in the study and is willing to participate in the study.
排除标准
- •Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers;
- •Patient receiving hyperbaric oxygen therapy (HBOT), negative pressure wound therapy (NPWT), bioengineering skin (BES) substitutes and/or growth factors;
- •Patient which, in the opinion of the investigator, may not comply with study related procedures;
- •Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator's discretion);
- •Being pregnant or breastfeeding;
- •Currently participating in another clinical trial or having participated in a previous clinical trial with receipt of an investigational product within 30 days of the first administration of IP;
- •A condition that, in the opinion of the Investigator, could compromise the well-being of the patient or course of the study, or prevent the patient from meeting or performing any study requirements;
- •Participants with hypersensitivity to any component of investigational products.
研究组 & 干预措施
TP-102
Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine.
干预措施: TP-102 (Biological)
Placebo
Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine.
干预措施: Placebo (Other)
结局指标
主要结局
3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4
时间窗: Week 4
1. Number and percentage of treatment emergent adverse events (TEAEs)
时间窗: From baseline to EOT, aproximately 12 weeks
See above
2. Mean DFUWI score (total AUC) for TP-102 versus Placebo
时间窗: From baseline to EOT, , aproximately 12 weeks
See above
次要结局
- 1. Change in mean CRP/ESR/PCT/WCC value for TP-102 versus Placebo(From baseline to EOT, , aproximately 12 weeks)
- 4. Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo at EOT;(EOT, , aproximately 12 weeks)
- 2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WCC(Baseline to EOT, , aproximately 12 weeks)
- 3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo at EOT;(EOT, , aproximately 12 weeks)