EUCTR2018-002913-37-BG进行中（未招募）1 期
Multicenter, prospective, randomized, double-blind, two-armed phase IV clinical study for efficacy and safety assessment of two 2% mupirocin containing nasal ointments (MupiroNasal 20mg/g, nasal ointment, Antibiotic-Razgrad AD, Bulgaria as test product and Bactroban 2%, nasal ointment, GlaxoSmithKline, United Kingdom as reference product), applied to the anterior nares in healthy subjects with nasal carriage of Staphylococcus aureus (S. aureus).
Antibiotic-Razgrad AD0 个研究点目标入组 260 人开始时间: 2018年12月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- •Male or female subject between 18 to 75 years inclusive;
- •Judged clinically healthy from a medical history and medical examination (vital signs, axillary body temperature);
- •Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;
- •Negative pregnancy test for the women with reproductive potential;
- •Reliable and acceptable method of contraception for the women of child-bearing potential:
- •Asymptomatic S. aureus carriage has been established in two sequential microbiological swabs in both right and left anterior nares;
- •Treatment area amenable to topical treatment, i.e. anterior nares should be free of any obstructions and tissue damage.
- •In the investigator’s opinion, the subject is capable of giving informed consent;
- •In the investigator’s opinion, the subject is able to understand, willing and likely to fully comply with study procedures and restrictions;
- •The subject is able to attend all visits, complete the study, and comply with the necessary restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Subjects with any physical or behavioral disorder, which, in the opinion of the Investigator, may interfere with the correct therapy with the IMPs or compliance with the Study Protocol requirements;
- •Subjects demonstrating any symptoms or sign of active infections or abnormality that may affect the microbiology tests or the treatment:
- •-wound lesions and/or infections in the treated area and/or the skin or the soft tissues;
- •-has active hay fever, on-going cold/flu symptoms, or a clinically significant history or currently active rhinitis;
- •-has any structural abnormalities of the nose or nasal piercings;
- •Any clinically significant allergy, including known allergy to mupirocin or any of the excipients or known drug intolerance;
- •Use of concomitant medication, such as:
- •-use of systemic or topical antibiotics (including mupirocin) or systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to Day 0;
- •-use of any prescribed medication in the 2 weeks prior to Day 0;
- •-use of any non-prescribed medication (including herbal remedies, nutritional supplements or vitamins and minerals) in the 1 week prior to Day 0;
- •-participation in a clinical study where the final dose of a New Chemical Entity occurred within the previous 16 weeks to Day 0;
- •-participation in a clinical study where the final dose of a marketed drug occurred within the previous 12 weeks or at least 5 half-lives (whichever is longest) of Day 0.
- •Subjects suffering from or with a history for systemic diseases or alterations, such as: haematological, dermatological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, neurological disease;
- •Subjects, suffering from or who have history of immune system disorders, such as autoimmune diseases, HIV positive status, history of immune system degradation or recurrent herpes simplex or who are undergoing treatment with immunosuppressors or immunotherapy;
- •Subjects who suffer from another medical condition or who are receiving medication that in the Principal Investigator’s judgment would prohibit inclusion in the study;
- •History of known alcohol or substance abuse;
- •Refusal to sign the Informed Consent Form.
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