EUCTR2015-004814-84-NL进行中（未招募）1 期
Individualized dosing of aminoglycosides, quinolones and glycopeptide antibiotics in (morbidly) obese patients - AMIGO
Sint Antonius Hospital0 个研究点目标入组 112 人开始时间: 2016年5月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
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
- •Inclusion criteria for (morbidly) obese participants:
- •-Indication for bariatric surgery (i.e. BMI > 40 kg/m2 or BMI > 35 kg/m2 with additional risk factors). Bariatric surgery includes the following: laparoscopic gastric bypass surgery or laparoscopic sleeve gastrectomy. We will equally stratify subjects to 4 weight groups: 100-120 kg, 120-145 kg, 145-170 kg and >170 kg;
- •-Participants between 18 - 60 years old;
- •-ASA physical classification of II or III;
- •-Participant is able and willing to sign the Informed Consent before screening evaluations.
- •Inclusion criteria for controls (normal weight participants):
- •-BMI between 18 and 25 kg/m2;
- •-Participants between 18 - 55 years old;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •-Renal insufficiency identified by eGFR < 60 ml/min/1.73m2. A recent serum creatinine (measured in the previous year) has to be known to assess this criterion. When not available, the patient’s own general practioner or pharmacy can be contacted for a recent serum creatinine. This is only done with oral consent from the patient. If not available, then serum creatinine is measured before the study drug is administered (see study procedures) with priority);
- •-Known allergy to the administered drug;
- •-Recent use of the study drug (up to 7 days before administration of the study drug);
- •-Treatment with the concerning study drug up to 7 days before administration of the study drug.
- •-Pregnancy or breastfeeding. This is an exclusion criteria for bariatric surgery as well (participants are informed by their surgeon and bariatric nurse). Women of childbearing potential using contraception are allowed to participate in the study.
- •Specific exclusion criteria for participants receiving an aminoglycoside or vancomycin:
- •-Participant who are treated with known nephro- or ototoxic drugs (immunosuppressants, antivirals, antineoplastic agents, ACE-inhibitors, lisdiuretics, aminoglycosides, vancomycin) up to 7 days before administration of the study drug. For NSAIDs, participants are not allowed to use a NSAID 24 hours before administration of the study drug (with the exception of meloxicam (72 hours), nabumeton (72 hours) or piroxicam 7 days).
- •Specific exclusion criteria for participants receiving ciprofloxacin IV:
- •-Known liver disease identified by liver function tests: ASAT, ALAT, prothrombin time, ?-GT, bilirubin, or alkaline phosphatase (ALP) (> 3 times upper limit of normal values)
- •-Known prolonged QT-interval or participants that use drugs that are known to prolong the QT-interval (based on the list published by CredibleMeds®, formerly known as AZCERT)
- •-Myasthenia gravis
- •-Porphyria cutanea tarda
- •-Psychoses in history
- •-Participants that use drugs that are known to be metabolized by CYP1A2 or CYP3A4
- •Additional exclusion criteria for participants receiving ciprofloxacin PO:
- •-Participants that use oral drugs that contain bivalent cations (calcium, magnesium, aluminum or iron), phosphate binders (sevelamer) or sucralphate, antacids or influence gastric emptying (see Appendix1) less than 6 hours before administration of ciprofloxacin.
- •For healthy volunteers a few extra prohibitions apply to participation (these are standard prohibitions employed in the CRCN):
- •-Water is allowed as desired except for one hour before and one hour after administration of study medication.
- •-From four hours after dosing until release of confinement, consumption of available beverages is free and meals are standardized in regard to consumption and time of administration.
- •- No history of alcohol or drugs abuse (up until one month before study drug administration).
- •-Subjects may not consume alcoholic beverages from 24 hours before until 48 hours after administration of study medication.
- •-Subjects may not use grapefruit containing food or juice, or St John’s worth, from 7 days before until the end of the study.
- •-Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal.
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