CTRI/2023/11/059899招募中2 期
A phase 2b clinical study to evaluate the safety and efficacy of topical administration of Bacteriophage therapy TP-102 in patients with Diabetic foot infection. - NI
TechnoPhage0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Aged > 18 years old.
- •2. Established diagnosis of Diabetes mellitus (Type I or Type II)
- •3. Glycosylated hemoglobin (HbA1C) value < 12.0 %
- •4. Designated foot infection meets the following criteria-
- •a.Present for at least 3 weeks
- •b.Below -ankle, full thickness, cutaneous ulcer.
- •c.Wound area (after debridement, if applicable) below or equal to 20.0 cm2
- •d.IWGDF/IDSA classification of Mild to moderate /PEDIS infection grade 2 or 3
- •e.PEDIS perfusion grade 1 or 2
- •f.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)
- •5. 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-
- •6. Patients with suitable physical and mental health as determined by the Investigator based on medical history and general physical examination.
- •7. Patients with childbearing potential must have a negative Serum Pregnancy Test at screening-
- •8. Female and male participants of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use one of the following forms of birth control whilst receiving study medications and for 4 (four) weeks after stopping study medications:
- •a. Male or female condoms
- •b. Diaphragm or cervical cap with spermicide (if available)
- •c. Intrauterine device (IUD)
- •d. Oral contraceptive or Depo-Provera
- •Note A: Female participants who are not of reproductive potential are eligible without the use of contraceptives. Participant reported history is acceptable documentation of menopause (i.e., at least one-year amenorrheic), hysterectomy or bilateral oophorectomy or bilateral tubal ligation; these participants are all considered not of reproductive potential.
- •Note B: Male participants who are not of reproductive potential (i.e., documented azoospermia) or whose female partner/s are not of reproductive potential (as defined above) are eligible without requiring the use of contraceptives.
- •9. ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose and procedures required in the study and is willing to participate.
排除标准
- •1.Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers.
- •2. Patient receiving Hyperbaric Oxygen Therapy (HBOT), Negative Pressure Wound Therapy (NPWT), Bioengineering Skin (BES) substitutes and/or growth factors.
- •3. Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator’s discretion);
- •4. Being pregnant or breastfeeding;
- •5. 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;
- •6. 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;
- •7. Patient which, in the opinion of the investigator, may not comply with study related procedures;
- •8. Participants with hypersensitivity to any component of investigational products
研究者
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