CTIS2023-506205-18-00进行中（未招募）1 期
A single blind, placebo controlled, single center, randomized controlled pilot study to assess if low dose ciprofloxacin can induce antimicrobial resistance in Escherichia coli - ITM202301
Institute Of Tropical Medicine0 个研究点目标入组 50 人开始时间: 2023年8月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Able and willing to provide written informed consent, At least 18 years old, Not taking any immunosuppressive agents and not clinically immunocompromised at the time of randomization, For females of childbearing potential only, willingness to practice continuous effective contraception during the study and a negative pregnancy test at the screening visit. Note: In accordance with ICH M3, the following will be classified as ‘effective contraception’: implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner.
排除标准
- •Use of any antibiotics in the previous 2 months of Visit 1, Known contra-indications or allergy to ciprofloxacin, Presence of any other condition, that will (likely) require the administration of another antibiotic at the time of randomization, as assessed by the treating physician, Pregnant or breastfeeding, Negative culture for E. coli at Visit 2
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