EUCTR2011-002438-38-GB进行中（未招募）不适用
An open-label, multiple dose, efficacy study of HT61 in combination with marketed antibiotics, applied to the anterior nares in subjects with nasal carriage of Staphylococcus aureus (S. aureus). - (duplicate) An efficacy study of HT61.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 96
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
- •To be eligible for inclusion, each subject must fulfil each of the following criteria:
- •1.Male or female between 18 to 65 years inclusive.
- •2.Judged healthy from a medical history, routine laboratory investigations, vital signs and 12-lead ECG.
- •3.Capable of giving informed consent.
- •4.Able to understand, willing and likely to fully comply with study procedures and restrictions.
- •5.Able to attend all visits and complete the study and comply with the necessary restrictions.
- •6.Male or female subject who is using a medically acceptable method of contraception or females of non-childbearing potential.
- •7.Treatment area amenable to topical treatment, i.e. anterior nares should be free of any obstructions and tissue damage.
- •8.Subject who tests positive for S. aureus carriage in both right and left anterior nares
- •9.Subject who tests negative for S. aureus carriage in the throat.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Subjects will be excluded from the study if any of the following criteria are met at screening:
- •1.Subject has wound lesions.
- •2.Any clinically significant allergy, including allergy to Arachis oil (peanut oil), neomycin, chlorhexidine, mupirocin or glycerine ester or drug intolerance.
- •3.Active hay fever, on-going cold/flu symptoms, or a clinically significant history or currently active rhinitis.
- •4.Any structural abnormalities of the nose or nasal piercings
- •5.Use of concomitant systemic or topical antibiotics or systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to Day 1. Use of any prescribed medication in the 2 weeks prior to Day 1 and use of any non-prescribed medication (including herbal remedies, nutritional supplements or vitamins and minerals) in the 1 week prior to Day 1 (inclusion of subjects who have taken medication will be assessed on a case-by-case basis in relation to the safety aspects and objectives of this study).
- •6.Participation in a clinical study where the final dose of a New Chemical Entity occurred within the previous 16 weeks to Day 1; or 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 1.
- •7.Clinically significant history or presence of any: haematological, dermatological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, neurological disease; any known or suspected immunodeficiency; any history or signs or symptoms of cancer; or a history or presence of any other disorder that may affect the conduct or outcome of the study.
- •8.History or pre-existing prolongation of QTc interval, cardiac arrhythmias or conduction defects on a 12-lead ECG.
- •9.A positive HIV 1 & 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result.
- •10.Donation of 450ml or more blood within the previous 12 weeks to Day 1.
- •11.Known or suspected drug abuse including a history of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units. One unit is equivalent to a half-pint of beer or one 25 mL measure of spirits or one small glass of wine.
研究者
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