Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
研究概览
简要总结
The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.
详细描述
When required, due to an infection, patients with short bowel syndrome will be treated with an intravenous antibiotic. The pharmacokinetic profile of that intravenous antibiotic will be determined. Once the full treatment with the intravenous antibiotic is over, the patient will be orally administered the same antibiotic, with determination of the oral pharmacokinetic profile, and both profiles will be compared, assessing the bioavailability of the oral antibiotic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Short bowel syndrome
- •Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim
- •Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of the Regional University Hospital of Nancy
- •Affiliated to a social security system
- •Having received an physical examination before entering study
- •Having received full information regarding the study organization and having signed the informed consent
排除标准
- •Patient at risk of worsening their oral absorption abilities during study
- •Patient requiring dialysis
- •Women of childbearing age without efficient birth control
- •Allergy to any of the drugs tested
- •Person concerned by Articles L. 1121-5, L. 1121-7 et L1121-8 of the Code of public health
- •Person deprived of liberty or person undergoing psychiatric care pursuant to articles L. 3212-1 et L. 3213-1
研究组 & 干预措施
Amoxicillin
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
干预措施: Amoxicillin (Drug)
Ofloxacin
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
干预措施: Ofloxacin (Drug)
Levofloxacin
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
干预措施: Levofloxacin (Drug)
Sulfamethoxazole trimethoprim
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
干预措施: Sulfamethoxazole trimethoprim (Drug)
结局指标
主要结局
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
时间窗: Time +8 hours
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
次要结局
- Describe antibiotic absorption after oral administration in these patients(Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours)
- Assess link between length of remaining bowel and antibiotic absorption(At inclusion)
研究者
MICHOT Niasha
Principal Investigator
Central Hospital, Nancy, France