2023-507716-13-00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
Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.5 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年1月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].
研究概览
简要总结
Safety:
- Safety and tolerability of TP-102 as compared to Placebo, in addition to Standard of Care (SoC); Efficacy:
- Clinical improvement in diabetic foot infection classification (IWGDF/IDSA) of TP-102 as compared to Placebo, in addition to SoC;
- Effects of TP-102 on wound healing as compared to Placebo, in addition to SoC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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: 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.
结局指标
主要结局
Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].
Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].
Number and percentage of Treatment Emergent Adverse Events (TEAEs) [Day 1 (Baseline) to EOT];
Number and percentage of Treatment Emergent Adverse Events (TEAEs) [Day 1 (Baseline) to EOT];
Statistically significant change in the percentage of patients in the respective IWGDF/IDSA classes for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];
Statistically significant change in the percentage of patients in the respective IWGDF/IDSA classes for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];
次要结局
- Change in mean CRP/ESR/PCT/WBC count value for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];
- Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WBC count for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];
- Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo, in addition to SoC, at EOT;
- Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo, in addition to SoC, at EOT;
- Changes in wound size, depth, granulation and partial closure (25%, 50%, 75%)from baseline, for TP-102 versus Placebo, in addition to SoC [Day 3, 8, 15, EOT and EOS].
- Percentage of patients that achieve wound healing (complete wound closure) by EOS for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to FUP2].
- Total Area Under the Curve (AUC) of the mean DFUWI score for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].
研究者
Margarida Barreto
Scientific
Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.
研究点 (5)
Loading locations...
相似试验
招募中
2 期
A Safety and Efficacy Study of GTX-102 in Subjects with Deletion- or Nondeletion-type Angelman Syndrome (Aurora)Angelman Syndrome2024-519393-39-00Ultragenyx Pharmaceutical Inc.19
尚未招募
1 期
A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological MalignanciesNCT07294300Qilu Pharmaceutical Co., Ltd.124
尚未招募
2 期
A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung CancerNCT07283198Jiangsu Alphamab Biopharmaceuticals Co., Ltd160
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18
招募中
1 期
A Study of Lutetium [177Lu]-BL-ARC001 in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid TumorsBreast CancerLung CancerNCT07274852Sichuan Baili Pharmaceutical Co., Ltd.22