CTIS2023-507716-13-00进行中（未招募）1 期
A Phase 2b Clinical Study to Evaluate the Safety and Efficacy of Topical Administration ofBacteriophage Therapy TP-102 in Patients with Diabetic Foot Infection - TP-102_102
Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.0 个研究点目标入组 80 人开始时间: 2023年9月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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: 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)., 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 with suitable physical and mental health as determined by the Investigator based on medical history and general physical examination;, A woman of childbearing potential (WOCBP) (including egg donors) must have a negative Serum Pregnancy Test at screening, WOCBP 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.Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: a.Oral b.Intravaginal c.Transdermal b.progestogen-only hormonal contraception associated with inhibition of ovulation: a.Oral b.Injectable c.implantable c.Intrauterine device (IUD) d.Intrauterine hormone-releasing system (IUS) e.Bilateral tubal occlusion f.Vasectomised partner g.Sexual abstinence, 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;, 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;, Patient which, in the opinion of the investigator, may not comply with study related procedures;, Participants with hypersensitivity to any component of investigational products.
研究者
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