A prospective, randomized, double-blind, placebo-controlled Phase I/IIa Clinical Trial to demonstrate the safety and efficacy of DUOFAG® in bacterial infection treatment in patients with surgical wounds
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- For Cohort 1: The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP.
研究概览
简要总结
The primary objective of the study is to demonstrate the safety of the product and the clinical and microbiological change within 10 weeks after the start of treatment or until healing.
研究设计
- 研究类型
- Interventional
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
- •Patients with surgical wound infection and/or dehiscence
- •Wound infected by S. aureus and/or P. aeruginosa according to wound swab.
- •Wound in the groin or any other skin fold as per Investigator’s discretion.
- •Signed Informed Consent Form, approved by the EC and CA
- •The age between 18 and 75 years.
- •Patients able and willing to comply with study procedures.
- •There are no contraindications for planned concomitant medication.
- •Persisting symptoms of bacterial infection < 3 weeks since the surgery.
- •Women of childbearing potential must take highly effective contraceptive measures since the study start and one month after the treatment administration at a minimum.
排除标准
- •History of an organ or bone marrow transplantation.
- •Hypersensitivity to the IMP or placebo.
- •Any autoimmune disease
- •Uncompensated diabetes mellitus, confirmed by the concentration of HbA1c >60 mmol/mol (6%).
- •Systematic immunosuppressive therapy.
- •Malignancy treatment <1 year before the Baseline visit.
- •COVID-19 infection <3 months before the Baseline visit, any signs of post-COVID syndrome.
- •Pregnancy or planning to become pregnant during the study.
- •Breastfeeding.
- •Participation in another clinical study.
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
For Cohort 1: The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP.
For Cohort 1: The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP.
For pooled Cohorts 1 & 2: Time to commencement of healing. The commencement of healing is defined as the composite measure when both the following conditions must be true: the granulation process in the wound has started, as indicated by the score ≤ 2 in each of the 3 items A8 – A10 of the mLUMT scale, the S. aureus and/or P. aeruginosa infection has been eradicated, i.e., the swab sample is negative on both S. aureus and P. aeruginosa.
For pooled Cohorts 1 & 2: Time to commencement of healing. The commencement of healing is defined as the composite measure when both the following conditions must be true: the granulation process in the wound has started, as indicated by the score ≤ 2 in each of the 3 items A8 – A10 of the mLUMT scale, the S. aureus and/or P. aeruginosa infection has been eradicated, i.e., the swab sample is negative on both S. aureus and P. aeruginosa.
次要结局
- Safety endpoints: The frequency of the following symptoms following the IMP application will be evaluated: • local reactions (local rash onset, local sensations, worsening of local inflammatory signs, discharge) • systemic reactions (vital signs reactions, fever, rash, arthralgia, gastrointestinal symptoms).
- Microbiological endpoints: Change of the microbiological profile of the wound assessed by swab (maximum 8 assessment points).
- Clinical efficacy endpoints: mLUMT total score change since Baseline; Time since the start of the study treatment until the bacterial infection eradication – i. e. the swab sample is negative on S. aureus and/or P. aeruginosa; Time since the start of the study treatment until the granulation process in the wound has started, as indicated by the score ≤ 2 in all 3 items A8 – A10 of the mLUMT scale; Time since the start of the study treatment until the wound is closed as assessed by Investigator.
研究者
Dana Stverakova
Scientific
MB PHARMA s.r.o.