Prospective, multi-center, randomized, double-blinded, placebo-controlled phase IIb clinical trial to evaluate safety and efficacy of DUOFAG® in bacterial infection treatment in patients with complicated wounds
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety: frequency of all serious (local and systemic) adverse reactions and events (see description in the relevant chapter) suspected or confirmed to be related to IMP administration during the IMP administration phase (0-14 days)
研究概览
简要总结
To demonstrate safety and efficiency of IMP – reduction of presence or to achieve complete eradication of S. aureus and/or P. aeruginosa during 14 days of IMP application, evaluated by the wound swab and stamp examination.
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
- •Subject with acute wound (surgical site or traumatic wound) infection and/or subject with complicated wound (chronic wound or complication of acute wound) infection
- •A wound infected with S. aureus and/or P. aeruginosa as determined by a wound swab
- •Strain isolated from wound swab is susceptible to IMP (as assessed by local laboratory)
- •Subject aged 18 to 80 years
- •No contraindications to the planned medication
- •Subject has provided written Informed consent and is willing and able to comply with the trial requirements
- •A man or woman who can no longer conceive a child (at menopause or after removal of the uterus and/or ovaries) or a woman who has a negative pregnancy test at the first visit and agrees to use an effective method of contraception
排除标准
- •Condition after organ or bone marrow transplantation
- •Subject is participating in another clinical trial evaluating a drug or medical device that has not completed evaluation of the primary endpoints
- •Subject has other comorbidities or pathologies that, in the opinion of the Investigator, preclude the subject from participating in the clinical trial
- •Wound infection with an epidemiologically serious bacterial strain other than S. aureus or P. aeruginosa
- •Malignancy treatment <1 year prior to the Baseline visit
- •Pregnant women or women planning to become pregnant during the clinical trial
- •Women who are breastfeeding
- •Hypersensitivity to the IMP or placebo component
- •Subject with acute or chronic renal failure requiring dialysis
- •Subject undergoing immunosuppressive therapy (excluding conventional doses of corticosteroids)
- •Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol
结局指标
主要结局
Safety: frequency of all serious (local and systemic) adverse reactions and events (see description in the relevant chapter) suspected or confirmed to be related to IMP administration during the IMP administration phase (0-14 days)
Safety: frequency of all serious (local and systemic) adverse reactions and events (see description in the relevant chapter) suspected or confirmed to be related to IMP administration during the IMP administration phase (0-14 days)
Efficiency (1): presence of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application
Efficiency (1): presence of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application
Efficiency (2): number of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application
Efficiency (2): number of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application
次要结局
- Occurrence and frequency of all (local and systemic) adverse reactions during the treatment and follow-up phase with a suspected or confirmed relatedness to IMP administration
- Change in mLUMT score during the treatment and follow-up phase
- Time from the start of IMP administration to the point of bacterial infection eradication - negative swab for S. aureus and/or P. aeruginosa
- Time from the start of IMP administration until complete wound healing (if this occurs during treatment or follow-up phase)
- Evaluation of possible differences in efficacy in inpatient and outpatient settings
研究者
Dana Stverakova
Scientific
MB PHARMA s.r.o.