EUCTR2011-002001-30-DE进行中（未招募）1 期
Multicenter, prospective, double-blind, two-armed phase III study for efficacy and safety of the topic impetigo therapy of two 2 % mupirocin ointments - Impetigo therapy safety of two mupirocin ointments
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent of both parents/legal guardians
- •- Clinically diagnosed impetigo
- •- Skin Infection Rating Scale SIRS = 4
- •- = 3 SIRS categories existing
- •- Detection of staphylococcus aureus and/or streptococcus pyogenes in the initial swab from the affected spot
- •- 28 days up to 15 years of age
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Necessity of a systemic therapy with antibiotics due to the severity and/or expansion of the impetigo or of a concomitant infection
- •- Extensively infected skin areas
- •-Affection of critical body regions as the auditory canal and the corner of the eye
- •-Impetigo as a secondary infection of a bite injury
- •- Impetigo in the area of central venous catheters
- •- Intranasally located impetigo
- •-Dermatological diseases that could impair the assessment of the impetigo (e. g. ecthyma, furunculosis, abscess, contact dermatitis, bite injuries)
- •-Clinically relevant primary or secondary immunodeficiency
- •-Current or less than 6 months dating back malign tumour diseases, chemotherapy, or radiotherapy
- •-Inadequately adjusted clinically relevant diabetes
- •- Known moderate or severe renal insufficiancy
- •-Other severe diseases that the investigator assesses as conflicting with the participation
- •-Systemic or dermal therapy with antibiotics, antimycotics, or corticoids during the past 7 days
- •-Dermal application of antiseptics during the past 7 days
- •-Girls of child-bearing potential
- •-Known intolerance to macrogol or mupirocin
- •- Inability of the parents to understand the instructions of the study
- •- Obvious unreliability of the parents or missing willingness to cooperate
- •- Known addiction of the parents to alcohol, medicaments, or drugs
- •- Limited legal competence of the parents or juricically/regulatorily ordered commitment to an institution
- •- Dependency of the child or the parents on the sponsor or on an investigator
- •- Participation in a clinical trial during the past 30 days
- •- Previous participation in the present clinical trial
研究者
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