2024-517434-17-01
尚未招募
4 期
Influence of antibiotic treatment on the normal flora and the presence of resistance genes in known carriers of ESBL and VRE
Region Uppsala2 个研究点 分布在 1 个国家目标入组 60 人2024年10月25日
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Region Uppsala
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1 a) Transition from negative to positive fecal screen for VRE/EPE directly after antibiotic challenge. 1b) Differences in the microbiota's composition and diversity compared to before antibitoic challenge.
- 状态
- 尚未招募
- 最后更新
- 去年
概览
简要总结
To evaluate the dynamics of carriage [of resistant bacteria] upon introduction of antibiotic challenge.
研究者
Regionens hus, Uppsala
Scientific
Region Uppsala
入排标准
入选标准
- •Signed consent, >18 years of age, Verified carriage of VRE/EPE in screening or clinical culture, Negativity in latest screening for VRE/EPE, For EPE carriers the isolate must be ressitant (R) to ciprofloxacin, Adquate contraception for fertile women (as recommended bythe CTFG)
排除标准
- •Known allergy to ciprofloxacin or contraindication for ciprofloxacin treatmen (for EPE arm), kidney failure as defined by creatinin clearance < 30 ml/min/1,73 m3 or serum creatinin > 168 µmol (for EPE arm), significant interaction with ciprofloxacin (EPE arm), known allergy or contraindication for vancomycin (VRE arm), pregnancy or breastfeeding, other morbidity or condition which makes the person ineligible for inklusion
结局指标
主要结局
1 a) Transition from negative to positive fecal screen for VRE/EPE directly after antibiotic challenge. 1b) Differences in the microbiota's composition and diversity compared to before antibitoic challenge.
1 a) Transition from negative to positive fecal screen for VRE/EPE directly after antibiotic challenge. 1b) Differences in the microbiota's composition and diversity compared to before antibitoic challenge.
次要结局
- 2a) Time for participants who transitioned from negative to positive VRE/EPE carriage to transition back to negative. 2b) Time for the intestinal microbiota's composition and diversity to return to baseline. 2c) Differences regarding detection of resistance in with conventional methods compared to metagenomic methods, defined as discordant results.
研究点 (2)
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