European Randomised Clinical Trial on mPOX Infection (EPOXI)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 335
- 试验地点
- 13
- 主要终点
- Time (days) to complete lesion resolution, counted from start of therapy, assessed at day 28 after randomisation and defined as the first day on which all lesions are completely healed with a new fresh layer of skin. For skin lesions, typically this means the lesion has scabbed, desquamated and new layer of skin formed (if a scar present, this is still defined as complete lesion resolution). For mucosal lesions, the phase of scabbing and desquamation is absent, and healing with new layer of skin
研究概览
简要总结
The trial aims to provide evidence about the clinical efficacy, as assessed by time to resolution of cutaneous and mucosal lesions, of a treatment versus control group of patients with proven mPOX.
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
- •PCR/NAAT-confirmed mPOX infection
- •The presence of active skin or mucosal lesion(s)
- •Signed informed consent
排除标准
- •Age <18 years
- •Pregnant and breastfeeding patients are not eligible for inclusion in this study
- •Lack of mental capacity to provide informed consent
- •Trial participation is considered not in the best interest of patient
结局指标
主要结局
Time (days) to complete lesion resolution, counted from start of therapy, assessed at day 28 after randomisation and defined as the first day on which all lesions are completely healed with a new fresh layer of skin. For skin lesions, typically this means the lesion has scabbed, desquamated and new layer of skin formed (if a scar present, this is still defined as complete lesion resolution). For mucosal lesions, the phase of scabbing and desquamation is absent, and healing with new layer of skin
Time (days) to complete lesion resolution, counted from start of therapy, assessed at day 28 after randomisation and defined as the first day on which all lesions are completely healed with a new fresh layer of skin. For skin lesions, typically this means the lesion has scabbed, desquamated and new layer of skin formed (if a scar present, this is still defined as complete lesion resolution). For mucosal lesions, the phase of scabbing and desquamation is absent, and healing with new layer of skin
次要结局
- Time (days) to active lesion resolution, defined as the first day on which all skin lesions are scabbed or desquamated (and mucosal lesions healed), with follow-up up to 28 days after randomisation.
- Status of the lesions on day 7, 14, 21 and 28 according to an ordinal scale. The ordinal scale is a) all lesions completely resolved (all scabs dropped off and intact skin remains underneath, and all mucosal lesions healed), b) active lesions resolved (all skin lesions scabbed or desquamated, but not fully resolved), c) active lesions persist but no new lesions in last 24 hours, d) new lesion(s) in last 24 hours.
- Time to resolution of symptoms. Symptoms are assessed by self-assessment and include fatigue, malaise, nausea, vomiting, abdominal pain, anorexia, cough, dysphagia, odynophagia, fever, headache, oral pain, pain with urination, rectal/anal pain. Signs will be evaluated at study visits only, including lymphadenopathy and proctitis, and are not included in the evaluation of symptoms.
- Occurrence of a negative monkeypox PCR of skin or mucosa swab, assessed for the most active skin or mucosa lesion at days 7, 14 and 28.
- Persistence of scars and skin discoloration, assessed on day 90 (and day 60 if the visit is live).
- Change from baseline in quality of life on day 7, 14, 28 and 90 by the Dermatology Quality of Life Index (DQLI)
- All-cause mortality within 28 days and within 90 days, applicable to all patients
- Time to complication, all-cause admission to hospital or all-cause death, within 28 days and 90 days, applicable to outpatients only.
- Frequency of AEs, SAEs and SUSARs for the specific therapeutic, within the first 28 days, but also assessed during the total follow-up (up to day 90)
- In a subset of patients with pain at lesion site (or proctitis) at baseline: Resolution of pain, by measuring (a) time to resolution of pain assessed by the Numeric Rating Scale (NRS) for pain (Karcioglu 2018), (b) time to cessation of the use of analgesic medication, defined as time to consistently reporting no use of analgesia for monkeypox-related lesions, up to 90 days after randomisation. (c) anal pain on days 7, 14, 28, 60 and 90 assessed by the Health Related Symptom Index
研究者
Miquel Ekkelenkamp
Scientific
University Medical Center Utrecht