NCT02030912已完成4 期
Phase 4 Study Into the Effect of Minocycline and Amoxicillin Administration of the Prevalence of Antibiotic Resistant Bacteria and on the Indigenous Oral, Faecal, Cutaneous and Nasal Microbiotas
Helperby Therapeutics Ltd1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of resistant bacteria collected from body sites in subjects receiving minocycline/ amoxicillin compared to the baseline.
研究概览
简要总结
A randomised, open labelled study design is selected in order to determine the emergence and persistence of antibiotic resistant bacteria in humans and on the composition of the indigenous microbiotas at various body sites. These will involve the administration to volunteers of minocycline and amoxicillin- a control group will receive a placebo. Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse events, vital signs, will be evaluated. The objectives of metagenomic analysis are:
- To identify the in vivo molecular mechanisms responsible for antibiotic resistance and its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome analysis.
- To determine the impact of the use of antimicrobial agents on the oral resistome
- To determine the impact of the use of antimicrobial agents on the faecal resistome
- To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous oral microbiota
- To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous faecal microbiotas
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18 and 40 years.
- •Following verbal & written information about the trial, the subject has signed & dated informed consent before any study related activity was carried out.
- •Subject legally competent and able to communicate effectively with the study personnel
- •Normal finding in the medical history and physical examination, unless the investigator considers an abnormality to be clinically irrelevant.
- •Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e., surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing or naturally postmenopausal for at least one year with a Screening FSH leve≥l 40 mIU/L). - - A negative serum pregnancy test is required at Screening for females.
排除标准
- •Regular use of medication, except contraceptive, vitamin tablets, treatment with antimicrobial agents within the 3 months preceding the study, Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics, Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit (Visit 2) .
- •Participation in a trial with another investigational drug within the 3 months preceding the study
- •Present or residual gastrointestinal, renal insufficiency or hepatic disorder
- •Abnormal pathology of nasal passages
- •Any clinically significant allergy or drug intolerance
- •Active hay fever, on-going cold/flu symptoms, including rhinitis at baseline (visit 2)
- •Any medical history of renal insufficiency or hepatic disorder or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •history of hypersensitivity to beta-lactams or tetracycline
- •pregnant or breast-feeding women
- •Subjects known or suspected of not being able to comply with trial protocol (e.g. alcoholism, drug dependency, or psychological state). History of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units for female and 28 units for male.
- •One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine.
- •Subjects with known or suspected immunodeficiency.
研究组 & 干预措施
3 doses of amoxicillin daily for 7 days
Active Comparator
Cohort A: 3 doses of amoxicillin daily for 7 days (n=14). Follow up 12 months.
干预措施: 3 doses of amoxicillin daily for 7 days (Drug)
2 doses of minocycline daily for 5 days
Active Comparator
Cohort B: 2 doses of minocycline daily for five days (n=14). Follow up 12 months.
干预措施: 2 doses of minocycline daily for five days (Drug)
2 doses of placebo daily for 5 days
Placebo Comparator
Cohort C: 2 doses of placebo daily for five days (n=14). Follow up 12 months.
干预措施: 2 doses of placebo daily for five days (Other)
结局指标
主要结局
Percentage of resistant bacteria collected from body sites in subjects receiving minocycline/ amoxicillin compared to the baseline.
时间窗: 12 Months
次要结局
- Adverse events (AEs) will be monitored throughout the study(12 Months)
研究者
研究点 (1)
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