NCT05177107终止2 期
Phase 2b Randomized, Parallel, Double-blind, Placebo-Controlled, Repeat Dose, Multi-Site Study for Safety, Tolerability, and Efficacy of Personalized Phage Treatment and SoC for Subjects With Diabetic Foot Osteomyelitis Due to S. Aureus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 15
- 主要终点
- Percent area reduction of study ulcer through Week 13
研究概览
简要总结
This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.
详细描述
This study will evaluate the safety and efficacy of bacteriophage therapy in subjects with diabetic foot osteomyelitis (DFO). Enrolled subjects will have osteomyelitis infections due to Staph aureus. This study will include eligible subjects who have undergone or are planning to undergo surgical debridement of DFO.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind:
Patient will be randomized to receive either active phage or placebo treatment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 to <85 years of age.
- •Ongoing diagnosis of diabetes.
- •Have undergone or are scheduled to undergo surgical debridement for DFO as part of SoC, with the associated bone culture positive for S. aureus
- •Availability of at least 1 matching phage for S. aureus cultured from the bone culture
- •Receiving SoC treatment for DFO, including antibiotics after debridement and before randomization
- •Meet defined study ulcer requirements as defined in the protocol
- •Adequate circulation to the affected extremity demonstrated within 3 months prior to randomization and no revascularization procedure anticipated
- •History of compliance with prior appointments and treatments in the investigator's opinion and willingness to receive and comply with SOC antimicrobial and clinical treatments for the study ulcer, including offloading
排除标准
- •Healing of the ulcer by more than 30% between screening and randomization.
- •Treated with hyperbaric oxygen or cellular/tissue products with 30 days of screening
- •Suspicion of neoplasm associated with the study ulcer or any non-study diabetic ulcer independent of biopsy result.
- •Presence of any cellulitis not localized to the study ulcer.
- •Indwelling hardware at the site of the DFO.
- •Body weight <50 kg.
- •Presence of above ankle ulcer, with >50% above medial malleolus
- •Hemoglobin < 7g/dL
- •Abnormal liver function tests
- •History of underlying liver disease at screening or within last 3 months
- •Positive test for HIV-1 and /or HIV-2
- •Any other clinically significant or severe disease that in the judgment of the investigator makes the patient unfit for the study or likely to withdraw prematurely from the study, or that could jeopardize the safety of the patient or confound the results of the study.
- •Known allergy to phage products.
- •Pregnant and/or breastfeeding.
- •Immunocompromised at screening in the judgment of the investigator.
- •Taking any systemic or topical antibacterial antibiotic within 2 weeks prior to the start of study treatment, for a condition other than Diabetic Foot Infection and DFO.
- •Taking any antiviral medication within 2 weeks prior to the start of study treatment and up through the last administration of study treatment.
- •Taking and/or receiving any therapies for the study ulcer that are not considered to be SOC.
- •More than 30 days has elapsed between screening and randomization (start of treatment)
- •Participating in another clinical trial within 4 weeks prior to screening.
- •Inability to obtain or provide informed consent or adhere to the protocol in the judgment of the investigator.
- •Once approximately 30% of subjects are enrolled with DFO involving digits, additional subjects will be excluded.
研究组 & 干预措施
Group 1: Phage Therapy
Experimental
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
干预措施: Bacteriophage Therapy (Biological)
Group 2: Placebo
Placebo Comparator
Placebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy).
干预措施: Placebo (Other)
结局指标
主要结局
Percent area reduction of study ulcer through Week 13
时间窗: Baseline through Week 13
Percent area reduction of the study ulcer surface area from baseline through Week 13
次要结局
- Microbiological eradication of the target pathogen(baseline through Week 13)
- Complete healing of the study ulcer(Baseline through Week 13)
- Time to 85% reduction of C-reactive protein (CRP)(Baseline through Week 13)
研究者
研究点 (15)
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